FDA Adverse Event
Injury
Summary report: N
AML LG STATURE 13.5MM
MDR report key: 2973825
·
Received February 22, 2013
Report
- Report Number
- 1818910-2013-12738
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- January 9, 2013
- Report Date
- July 10, 2023
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- KWA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
DATE RECEIVED BY MANUFACTURER: 2/1/2013. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77813 | AML LG STATURE 13.5MM | DEVICE | KWA | DEPUY ORTHOPAEDICS INC US | EB4EX1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention | ASPHERE M SPEC 12/14 40 +1.5.| PINNACLE 100 ACET CUP 58MM.| PINNACLE MTL INS NEUT40IDX58OD.| ZIMMER PIN STEINMAN (COMPETITOR). |