FDA Adverse Event
Injury
Summary report: N
PINN MAR LIP LNR 32IDX56OD
MDR report key: 1033573
·
Received April 23, 2008
Report
- Report Number
- 1818910-2008-01450
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 3, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K000306
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PROD AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS CHRONIC DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN MAR LIP LNR 32IDX56OD | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | ZG9CS1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |