FDA Adverse Event
Injury
Summary report: N
OXFORD ANATOMIC BEARING
MDR report key: 1893171
·
Received October 29, 2010
Report
- Report Number
- 3002806535-2010-00089
- Event Type
- Injury
- Date Received
- October 29, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 9, 2010
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- P010014
- Removal / Correction Number
- NA
- 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. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(6), 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT PRIMARY KNEE PROCEDURE ON (B)(6), 2006. PT UNDERWENT REVISION SURGERY ON (B)(6), 2010 DUE TO FOREIGN BODY IRRITATION FROM UNREMOVABLE CEMENT AT THE BACK OF THE KNEE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXFORD ANATOMIC BEARING | NRA | BIOMET UK LTD. | NA | 930317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |