FDA Adverse Event
Injury
Summary report: N
UNKNOWN TOTAL HIP
MDR report key: 6182369
·
Received December 16, 2016
Report
- Report Number
- 3002806535-2016-00902
- Event Type
- Injury
- Date Received
- December 16, 2016
- Date of Event
- June 16, 2005
- Report Date
- December 15, 2016
- Manufacturer
- BIOMET UK LTD.
- Product Code
- KWA
- PMA / PMN Number
- PNI
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 3002806535-2016-00902, 00903, 009804, 00905).
Description of Event or Problem · 1
PATIENT WAS REVISED APPROXIMATELY 15 YEARS POST-IMPLANTATION DUE TO AN UNKNOWN REASON. DURING THE PROCEDURE, THE MODULAR HEAD WAS REMOVED AND REPLACED AND A METAL LINER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831504 | UNKNOWN TOTAL HIP | PROSTHESIS, HIP | KWA | BIOMET UK LTD. | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |