DJO SURGICAL · EMPOWR Acetabular System, Liner, Neutral, HXe+, 40G
Encore Medical L.P · Adverse Event Without Identified Device or Use Problem
- Manufacturer contact t name
- Ms.
- Manufacturer contact state
- TX
- Manufacturer link flag
- Y
- Manufacturer g1 city
- Austin
- Manufacturer contact address 1
- 9800 Metric Blvd.
- Event type
- Injury
- Report number
- 1644408-2026-02018
- Product problem flag
- N
- Date received
- 20260930
- PMA pmn number
- K190057
- Date of event
- 20260916
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 78758
- Reporter occupation code
- 003
- Noe summarized
- 1
- Manufacturer contact l name
- Bonnell
- Manufacturer g1 postal code
- 78758
- Manufacturer g1 state
- TX
- Reporter country code
- US
- Date added
- 20260930
- Manufacturer contact f name
- Stacey
- Device date of manufacturer
- 20260811
- Previous use code
- I
- Reporter state code
- NJ
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260929
- Manufacturer g1 country
- US
- Manufacturer contact city
- Austin
- MDR report key
- 50941449
- Date manufacturer received
- 20260916
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 78758
- Manufacturer g1 name
- Encore Medical L.P
- Adverse event flag
- Y
- Single use flag
- Y
- Manufacturer g1 address 1
- 9800 Metric Blvd.
- Manufacturer contact postal code
- 78758
- Type of report
- Initial submission
- Source type
- Company representation
- Device
- Device sequence number
- 319557
- Implant date year
- 2026
- Date removed year
- 2026
- Serviced by 3rd party flag
- N
- Date received
- 20260930
- Brand name
- DJO SURGICAL
- Generic name
- EMPOWR Acetabular System, Liner, Neutral, HXe+, 40G
- Manufacturer d name
- Encore Medical L.P
- Manufacturer d address 1
- 9800 Metric Blvd.
- Manufacturer d city
- Austin
- Manufacturer d state
- TX
- Manufacturer d zip code
- 78758
- Manufacturer d country
- US
- Manufacturer d postal code
- 78758
- Device operator
- HEALTH PROFESSIONAL
- Catalog number
- 941-01-40G
- Lot number
- 604Z1294
- Device availability
- No
- Device report product code
- LPH
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 00190446309581
- UDI public
- 00190446309581
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3358
- Device class
- 2
- Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient
- Patient sequence number
- 1
- Patient problems
- Unspecified Infection