FDA Adverse Event
Injury
Summary report: N
MOST HINGE KIT
MDR report key: 1622285
·
Received March 2, 2010
Report
- Report Number
- 1822565-2010-00106
- Event Type
- Injury
- Date Received
- March 2, 2010
- Date of Event
- January 26, 2010
- Report Date
- February 10, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- HRZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
UPON SEPARATION OF THE DISTAL FEMUR, THE SURGEON NOTICED SOME BLACK SUBSTANCE ON THE MALE & FEMALE TAPER. SHE ALSO NOTED THAT THE JUNCTION BETWEEN THE SEGMENT AND THE STEM HAD NO GAP. ALSO, THE JUNCTION BETWEEN THE CONDYLAR END & SEGMENT HAD NO GAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOST HINGE KIT | KNEE PROSTHESIS | HRZ | ZIMMER, INC. | NA | 1371337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | MOST CONDYLAR END, CATALOG #031000001, LOT #11971 |