FDA Adverse Event
Injury
Summary report: N
ALT HA S NOCLR EXT SZ 7
MDR report key: 17774912
·
Received September 19, 2023
Report
- Report Number
- 1038671-2023-02313
- Event Type
- Injury
- Date Received
- September 19, 2023
- Date of Event
- August 29, 2023
- Report Date
- October 27, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- MEH
- UDI-DI
- 10885862321220
- PMA / PMN Number
- K162732
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PENDING INVESTIGATION. D10: 170-32-07 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +7MM 6218314. 01-030-40-0332 - ALT XLE LNR NTRL G3 32 A150675. 01-030-01-0348 - ALT CUP CLSTR G3 SZ 48 A381411. 180-65-30 - ALTEON 6.5MM SCREW, 30MM S399575.
Description of Event or Problem · 0
AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON (B)(6) 2023 AND HAS SINCE SUBSIDED. THE PATIENT WAS REVISED ON (B)(6) 2023 AND IMPLANTED WITH COMPETITOR'S DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR 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 |
|---|---|---|---|---|---|---|---|
| 2062160 | ALT HA S NOCLR EXT SZ 7 | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER | MEH | EXACTECH, INC. | 10885862321220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |