FDA Adverse Event
Injury
Summary report: N
BI-METRIC HA/PC 11X135MM
MDR report key: 2735939
·
Received September 7, 2012
Report
- Report Number
- 3002806535-2012-00252
- Event Type
- Injury
- Date Received
- September 7, 2012
- Date of Event
- July 4, 2012
- Report Date
- August 9, 2012
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- PMA / PMN Number
- PK030055
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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.THIS IS 2 OF 4 REPORTS RELATED TO THE SAME EVENT. (SEE 3002806535-2012-002512/254).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2006. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BI-METRIC HA/PC 11X135MM | PROSTHESIS, HIP | LPH | BIOMET UK LTD. | N/A | 1124206 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |