FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY TRI-LOCK STEM
MDR report key: 2946255
·
Received February 6, 2013
Report
- Report Number
- 1818910-2013-03786
- Event Type
- Injury
- Date Received
- February 6, 2013
- Date of Event
- September 4, 2012
- Report Date
- January 17, 2013
- Manufacturer
- DEPUY WARSAW
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
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.
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. (B)(4).
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE: (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE METAL HYPERSENSITIVITY AND CORROSION. THE SLEEVE AND STEM WERE ADDED TO COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50021 | UNKNOWN DEPUY TRI-LOCK STEM | STEM | JDI | DEPUY WARSAW | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |