FDA Adverse Event
Injury
Summary report: N
S-ROM M HEAD 36MM +0
MDR report key: 2992685
·
Received March 7, 2013
Report
- Report Number
- 1818910-2013-13367
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 8, 2013
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- PMA / PMN Number
- PK120599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.
Description of Event or Problem · 1
LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97870 | S-ROM M HEAD 36MM +0 | FEMORAL HEAD | LPH | DEPUY ORTHOPAEDICS INC US | 1981394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |