FDA Adverse Event
Injury
Summary report: N
ENDURANCE SZ 3 HIGH OFFSET
MDR report key: 1013871
·
Received March 14, 2008
Report
- Report Number
- 1818910-2008-00866
- Event Type
- Injury
- Date Received
- March 14, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 26, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- PMA / PMN Number
- K942370
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODE REQUIRED FOR RETRIEVAL WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
Description of Event or Problem · 1
PATIENT REVISED TO ADDRESS LOOSE FEMORAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDURANCE SZ 3 HIGH OFFSET | 87JDI | JDI | DEPUY ORTHOPAEDICS, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |