FDA Adverse Event
Injury
Summary report: N
NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS
MDR report key: 21890745
·
Received April 23, 2025
Report
- Report Number
- 1038671-2025-01871
- Event Type
- Injury
- Date Received
- April 23, 2025
- Date of Event
- April 2, 2025
- Report Date
- April 23, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- JDI
- UDI-DI
- 10885862024275
- PMA / PMN Number
- K070479
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. SEE H11: (B)(6) 188-01-07 - WEDGE PLASMA X/O SZ 7.
Description of Event or Problem · 0
AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 7 YEARS AND 4 MONTHS AGO. THE PATIENT STARTED HAVING PAIN AND SQUEAKING, SO THE SURGEON REVISED THE LINER AND HEAD. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 627453 | NV GXL LNR, +5LAT, 32MM G1-48/50MM CUPS | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | JDI | EXACTECH, INC. | 10885862024275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Hospitalization | SEE H11 |