FDA Adverse Event
Injury
Summary report: N
ASR XL ANATOMIC HEAD SIZE 49
MDR report key: 2121334
·
Received June 1, 2011
Report
- Report Number
- 1818910-2011-09185
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- February 2, 2011
- Report Date
- July 31, 2013
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.
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).
Description of Event or Problem · 1
THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR XL ANATOMIC HEAD SIZE 49 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2318500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |