FDA Adverse Event
Injury
Summary report: N
DEPUY SHOULDER SYSTEM
MDR report key: 7095600
·
Received December 6, 2017
Report
- Report Number
- MW5073799
- Event Type
- Injury
- Date Received
- December 6, 2017
- Date of Event
- November 5, 1909
- Report Date
- November 28, 2017
- Manufacturer
- DEPUY ORTHOPAEDICS INC.
- Product Code
- KWS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MY ORIGINAL SHOULDER KEEPS GOING OUT. THEY PUT A NEW ONE IN AND IT STILL DOES THE SAME THING, ONLY WORSE. IT GOES OUT 3 OR 4 TIMES A DAY. IF I HAD SURGERY ON IT 50/50 I WILL LOSE USAGE. REF # 1136-42-026 LOT # DP5MWA000 CROSSWALK ANCHOR SEG GLENOID. REF # 1128-48-110 LOT # C4HCI1000 SHOULDER ELECTRIC HEAD, REF # 1137-12-000, LOT # C44DCC000 STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 865869 | DEPUY SHOULDER SYSTEM | DEPUY SHOULDER SYSTEM | KWS | DEPUY ORTHOPAEDICS INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |