FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR FEMORAL HEAD
MDR report key: 2792610
·
Received October 16, 2012
Report
- Report Number
- 1818910-2012-76364
- Event Type
- Injury
- Date Received
- October 16, 2012
- Date of Event
- March 17, 2010
- Report Date
- September 21, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KXA
- Removal / Correction Number
- Z1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
LITIGATION ALLEGES PATIENT HAD PAIN, METAL-INDUCED SYNOVITIS/IMMUNE RESPONSE, ASEPTIC METAL INFLAMMATORY REACTION, TISSUE DEATH, HIGH CHROMIUM LEVELS AND LEG LENGTH INEQUITY AFTER ASR HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR FEMORAL HEAD | TOTAL HIP REPLACEMENT | KXA | DEPUY INTERNATIONAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |