FDA Adverse Event
Injury
Summary report: N
COCR FEMORAL BALL HEAD
MDR report key: 22573682
·
Received July 23, 2025
Report
- Report Number
- 3005180920-2025-00699
- Event Type
- Injury
- Date Received
- July 23, 2025
- Date of Event
- July 8, 2025
- Report Date
- July 22, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030805219
- PMA / PMN Number
- K080885
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 11-JUL-2025. BALL HEADS: COCR 01.25.031 COCR BALL HEAD 12/14 Ø36 MM SIZE M (K080885) LOT. 186285B: 1 ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2023. EXPIRATION DATE: 14-APR-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 3 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM THE COMPETITOR LINER. THE SURGEON REVISED AND UPSIZED ONLY THE HEAD TO GIVE THE PATIENT STABILITY TO DETER RECURRING DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1736935 | COCR FEMORAL BALL HEAD | COCR BALL HEAD 12/14 Ø36 MM SIZE M | JDI | MEDACTA INTERNATIONAL SA | 01.25.031 | 186285B | 07630030805219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |