FDA Adverse Event
Injury
Summary report: N
ALT HA S CLR STD SZ 5
MDR report key: 19754951
·
Received July 16, 2024
Report
- Report Number
- 1038671-2024-02405
- Event Type
- Injury
- Date Received
- July 16, 2024
- Date of Event
- June 25, 2024
- Report Date
- October 22, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- MEH
- UDI-DI
- 10885862321077
- PMA / PMN Number
- K162732
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(D10) CONCOMITANT DEVICE(S): (B)(6), 01-030-01-0450 - ALT CUP CLSTR G4 SZ 50; (B)(6), 01-030-40-0436 - ALT XLE LNR NTRL G4 36; (B)(6) 170-36-93 - BIOLOX DELTA FEMORAL HEAD 36MM OD, -3.5MM.
Description of Event or Problem · 0
APPROXIMATELY 12 DAYS AFTER LEFT THA, THE PATIENT WAS REVISED DUE TO SUBSIDENCE AND A LESSER TROCHANTER FRACTURE. THE STEM AND CERAMIC BALL WERE REVISED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THE EVENT IS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT DID NOT CAUSE A SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694527 | ALT HA S CLR STD SZ 5 | PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU | MEH | EXACTECH, INC. | 10885862321077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | SEE H11. |