FDA Adverse Event
Injury
Summary report: N
RINGLOC LINER
MDR report key: 1910734
·
Received November 23, 2010
Report
- Report Number
- 3002806535-2010-00096
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- August 30, 2010
- Report Date
- October 28, 2010
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LPH
- PMA / PMN Number
- K926107
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE US. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EVAL IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVAL, A F/U REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED ON (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT HIP PROCEDURE ON (B)(6) 1998. PT UNDERWENT REVISION SURGERY ON (B)(6) 2010 DUE TO WEAR. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RINGLOC LINER | LPH | BIOMET UK LTD. | NA | 243264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |