FDA Adverse Event
Injury
Summary report: N
S-ROM M HEAD 36MM +3
MDR report key: 4368724
·
Received December 30, 2014
Report
- Report Number
- 1818910-2014-35307
- Event Type
- Injury
- Date Received
- December 30, 2014
- Date of Event
- December 2, 2014
- Report Date
- December 3, 2014
- Manufacturer
- DEPUY INTERNATIONAL LTD 8010379
- Product Code
- LPH
- PMA / PMN Number
- PK120599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4)
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE REPORT OF 181910-2014-34076. THIS REPORT, 1818910-2014-35307 WILL BE REJECTED. 181910-2014-34076 WILL BE KEPT FOR INVESTIGATION PURPOSES.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
LITIGATION ALLEGES THE PATIENT SUFFERS FROM ELEVATED COBALT AND CHROMIUM LEVELS, POPPING, PAIN, DISCOMFORT, AND MOBILITY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 856827 | S-ROM M HEAD 36MM +3 | HIP FEMORAL HEAD | LPH | DEPUY INTERNATIONAL LTD 8010379 | 2756586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |