FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMP 58
MDR report key: 1772316
·
Received July 23, 2010
Report
- Report Number
- 1818910-2010-05130
- Event Type
- Injury
- Date Received
- July 23, 2010
- Date of Event
- April 29, 2010
- Report Date
- June 25, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE UNITED STATES UNDER A DIFFERENT PART NUMBER. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS LOOSENING, RESTRICTED RANGE OF MOVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR IMP 58 | TOTAL HIP REPLACEMENT | JDI | DEPUY INTERNATIONAL, LTD. | NA | 2021696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |