FDA Adverse Event
Injury
Summary report: N
MD HYBRID GLENOID BASE 4MM
MDR report key: 5890772
·
Received August 19, 2016
Report
- Report Number
- 0001825034-2016-03197
- Event Type
- Injury
- Date Received
- August 19, 2016
- Report Date
- July 21, 2016
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KWS
- PMA / PMN Number
- PK060694
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
PATIENT EXPERIENCED LEFT GLENOID RADIOLUCENCY PROGRESSION FROM 1 MM TO 2 MM IN ZONE 2 APPROXIMATELY ONE YEAR POST-IMPLANTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541434 | MD HYBRID GLENOID BASE 4MM | PROSTHESIS, SHOULDER | KWS | BIOMET ORTHOPEDICS | N/A | 307160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |