FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY TIBIAL HINGED INSERT
MDR report key: 1850857
·
Received September 28, 2010
Report
- Report Number
- 1818910-2010-07040
- Event Type
- Injury
- Date Received
- September 28, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 15, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KRO
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND SEARCH THE COMPLAINT DATABASE WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED INFECTION. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY TIBIAL HINGED INSERT | TOTAL KNEE REPLACEMENT | KRO | DEPUY ORTHOPAEDICS, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |