FDA Adverse Event
Injury
Summary report: N
TPRLC 133 MP TYPE1 PPS HO 16.0
MDR report key: 3030419
·
Received April 2, 2013
Report
- Report Number
- 3002806535-2013-00055
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- February 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- BIOMET UK LTD.
- Product Code
- KWA
- PMA / PMN Number
- PK101086
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH REPORT WAS RECEIVED. MANUFACTURING HISTORY RECORDS WERE REVIEWED FINDING NO DEVIATIONS OR ABNORMALITIES RELATED TO THE EVENT. NO PRODUCT WAS 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 THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON AN UNKNOWN DATE. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO A FRACTURE. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133960 | TPRLC 133 MP TYPE1 PPS HO 16.0 | PROSTHESIS, HIP | KWA | BIOMET UK LTD. | N/A | 2725418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |