FDA Adverse Event
Injury
Summary report: N
DURALOC DYNAMIC LOCK RING 52MM
MDR report key: 1870341
·
Received October 11, 2010
Report
- Report Number
- 1818910-2010-06991
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- PMA / PMN Number
- K902396
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT REVISED FOR OSTEOLYSIS AND POLYETHYLENE WEAR. INTEROPERATIVELY FOUND LOCKING RING BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURALOC DYNAMIC LOCK RING 52MM | 87JDI | JDI | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |