FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 20186467
·
Received September 10, 2024
Report
- Report Number
- 1644408-2024-01344
- Event Type
- Injury
- Date Received
- September 10, 2024
- Date of Event
- August 12, 2024
- Report Date
- October 7, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- KWS
- UDI-DI
- 00190446334972
- PMA / PMN Number
- K190290
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2022-00020; 530-14-048, S800 - REVISION SURGERY, S809 - TRAUMA, REVISION SURGERY. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Description of Event or Problem · 0
REVISION SURGERY - DUE TO UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1600698 | DJO SURGICAL | ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 10X48MM | KWS | ENCORE MEDICAL L.P. | 1492A1396 | 00190446334972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Required Intervention | 509-03-432 LOT: 954W1248 |