FDA Adverse Event
Injury
Summary report: N
PFC SIGMA/OV/DOME PAT 3PEG,38
MDR report key: 2121399
·
Received June 1, 2011
Report
- Report Number
- 1818910-2011-08621
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- April 4, 2011
- Report Date
- March 20, 2026
- Manufacturer
- DEPUY (IRELAND)
- Product Code
- JWH
- PMA / PMN Number
- K961685
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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
THE SURGEON CLAIMS THAT THE CEMENT USED DID NOT PERFECTLY ADHERE WITH THE IMPLANT DEVICES. IT RATHER REMAINED STUCK ON THE DEVICES THEMSELVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA/OV/DOME PAT 3PEG,38 | 87 JWH | JWH | DEPUY (IRELAND) | NA | 3056751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |