FDA Adverse Event
Injury
Summary report: N
HXL-VE 3D INSERT 10LX11MM
MDR report key: 19494872
·
Received June 8, 2024
Report
- Report Number
- 1644408-2024-00850
- Event Type
- Injury
- Date Received
- June 8, 2024
- Date of Event
- May 13, 2024
- Report Date
- August 1, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- OIY
- UDI-DI
- 00888912119269
- PMA / PMN Number
- K091956
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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: 1644408-2019-00036: 391-09-604, S807 - PAIN, 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 PATIENT IS HAVING DISCOMFORT SO THE DOCTOR WENT IN AND DID A POLY SWAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2326977 | HXL-VE 3D INSERT 10LX11MM | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER | OIY | ENCORE MEDICAL L.P. | 59602033 | 00888912119269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |