FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEPUY FEMORAL HEAD
MDR report key: 2760403
·
Received September 26, 2012
Report
- Report Number
- 1818910-2012-19429
- Event Type
- Malfunction
- Date Received
- September 26, 2012
- Report Date
- August 31, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KXA
- PMA / PMN Number
- K980513
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, FEELINGS OF LOOSENING, AND POPPING NOISES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY FEMORAL HEAD | TOTAL HIP REPLACEMENT | KXA | DEPUY INTERNATIONAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |