FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 52
MDR report key: 3031353
·
Received April 2, 2013
Report
- Report Number
- 1818910-2013-04240
- Event Type
- Injury
- Date Received
- April 2, 2013
- Date of Event
- March 25, 2013
- Report Date
- June 28, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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
DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN.
Description of Event or Problem · 1
**UPDATE**- MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION REPORT INDICATES PATIENT WAS HAVING PAIN AND DISCOMFORT; MRI SCAN SHOWED A LARGE PSEUDOTUMOR; LARGE AMOUNT OF FLUID FOUND UPON REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133520 | ASR ACETABULAR CUPS 52 | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | 2451948 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |