NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS
Report
- Report Number
- 1038671-2026-00634
- Event Type
- Injury
- Date Received
- May 20, 2026
- Report Date
- May 20, 2026
- Manufacturer
- EXACTECH, INC.
- Product Code
- JDI
- UDI-DI
- 10885862022165
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D10: 164-01-13 - VASTAGO ELEMENT S/COLLAR OFFSET STD. Nº13 (B)(6) 180-11-52 - (DISC) NOVATION CROWN CU P, CLUSTER-HOLE WITH HA, (B)(6) 01-032-03-3204 - UNIV.CUP CABEZA CERAM. DELTA 32 +4 (B)(6) THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
AS REPORTED, A PATIENT UNDERWENT AN INITIAL TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH EARLY WEAR OF THE PROSTHETIC POLYETHYLENE WITH PARTICULATE DISEASE, WAS ADMITTED TO THE HOSPITAL, AND NEEDS SURGICAL INTERVENTION TO PREVENT INJURY OR PERMANENT DISABILITY. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559813 | NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED | JDI | EXACTECH, INC. | 10885862022165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |