FDA Adverse Event
Injury
Summary report: N
PRSVN ALLPOLY TIB LMRL S2 7MM
MDR report key: 1954420
·
Received January 5, 2011
Report
- Report Number
- 1818910-2010-10840
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- HRY
- PMA / PMN Number
- K010810
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED FROM A UNI KNEE TO A TOTAL KNEE TO ADDRESS PAIN AND POLY WEAR OF THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRSVN ALLPOLY TIB LMRL S2 7MM | 87HRY | HRY | DEPUY INTERNATIONAL, LTD. | NA | 1045112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |