FDA Adverse Event
Injury
Summary report: N
S-ROM M 36MM HEAD +3
MDR report key: 1772324
·
Received July 23, 2010
Report
- Report Number
- 1818910-2010-04752
- Event Type
- Injury
- Date Received
- July 23, 2010
- Report Date
- June 23, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- PMA / PMN Number
- K851422
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
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.
Description of Event or Problem · 1
PATIENT REVISED FOR PAIN AND SOFT TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S-ROM M 36MM HEAD +3 | 87JDI | JDI | DEPUY INTERNATIONAL, LTD. | NA | 1143542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |