FDA Adverse Event
Injury
Summary report: N
32MM MOD HD COCR -6MM
MDR report key: 4081888
·
Received September 11, 2014
Report
- Report Number
- 3002806535-2014-00196
- Event Type
- Injury
- Date Received
- September 11, 2014
- Date of Event
- August 8, 2014
- Report Date
- August 12, 2014
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JDI
- PMA / PMN Number
- PK911684
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HIP SURGERY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561036 | 32MM MOD HD COCR -6MM | PROSTHESIS, HIP | JDI | BIOMET UK LTD. | N/A | 00J3059926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |