FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMPLANT 54
MDR report key: 3093518
·
Received May 6, 2013
Report
- Report Number
- 1818910-2013-05256
- Event Type
- Injury
- Date Received
- May 6, 2013
- Date of Event
- February 4, 2013
- Report Date
- April 24, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z- 1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.
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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.
Description of Event or Problem · 1
REVISION REASON: INCREASED METAL ION LEVELS.
Description of Event or Problem · 1
ASR REVISION; ASR XL - LEFT; REASON(S) FOR REVISION: PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196679 | ASR ACETABULAR IMPLANT 54 | ASR TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | 2850551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |