FDA Adverse Event
Injury
Summary report: N
DURALOC 1200 SERIES 64MM OD
MDR report key: 1210598
·
Received October 22, 2008
Report
- Report Number
- 1818910-2008-04915
- Event Type
- Injury
- Date Received
- October 22, 2008
- Date of Event
- October 14, 2008
- Report Date
- October 14, 2008
- Manufacturer
- DEPUY-RAYNHAM, A DIVISIN OF DEPUY ORTHOPAEDICS, INC
- Product Code
- LPH
- PMA / PMN Number
- K961186
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODES REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS INSTABILITY. POLY WEAR, OSTEOLYSIS, AND LOOSENING OF THE CUP WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURALOC 1200 SERIES 64MM OD | 87LPH | LPH | DEPUY-RAYNHAM, A DIVISIN OF DEPUY ORTHOPAEDICS, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |