FDA Adverse Event
Injury
Summary report: N
DJO SURGICAL
MDR report key: 20186456
·
Received September 10, 2024
Report
- Report Number
- 1644408-2024-01359
- Event Type
- Injury
- Date Received
- September 10, 2024
- Date of Event
- August 9, 2024
- Report Date
- December 12, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- KWS
- UDI-DI
- 00888912024785
- PMA / PMN Number
- K100741
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT D4 LOT NUMBER TO UNKNOWN AND EXPIRATION DATE TO UNKNOWN, H4 DEVICE MANUFACTURER DATE TO UNKNOWN AND ADD H10 RELATED REPORT NUMBER.
Additional Manufacturer Narrative · 0
D4 EXPIRATION DATE. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO: 1644408-2021-00891; 508-44-101, S803 - DISLOCATION, 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 DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1600687 | DJO SURGICAL | 44MM RSP GLEN HD +8MM | KWS | ENCORE MEDICAL L.P. | UNKNOWN | 00888912024785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Required Intervention | 509-01-044 LOT: 384P1016A.| 509-01-044 LOT: UNKNOWN.| 530-14-108 LOT: 415T1447.| 530-14-108 LOT: UNKNOWN. |