FDA Adverse Event
Injury
Summary report: N
DEPUY ASR FEM IMPLANT SZ 49
MDR report key: 2760054
·
Received September 26, 2012
Report
- Report Number
- 1818910-2012-75392
- Event Type
- Injury
- Date Received
- September 26, 2012
- Date of Event
- February 29, 2012
- Report Date
- August 27, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KXA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. REF. (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.
Additional Manufacturer Narrative · 1
THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.
Description of Event or Problem · 1
LITIGATION ALLEGES PATIENT HAD PAIN, DISABILITY AND PHYSICAL DAMAGE FROM CHROMIUM AND COBALT EXPOSURE AFTER ASR HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR FEM IMPLANT SZ 49 | TOTAL HIP REPLACEMENT | KXA | DEPUY INTERNATIONAL | 2753136 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |