FDA Adverse Event
Malfunction
Summary report: N
MOORE HIP PROSTHESIS LONG FENESTRATED STEM
MDR report key: 1030249
·
Received April 15, 2008
Report
- Report Number
- 2648920-2008-00023
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 26, 2008
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: PACKAGE REC'D EXCESSIVE SHOCK IN DISTRIBUTION HANDLING CAUSED PROD TO CRACK STERILE BARRIERS. PACKAGING CARTON, OUTER AND INNER CAVITIES SHOW DAMAGE NEAR SIMILAR LOCATION FROM EACH OTHER. DEVICE HISTORY RECORDS INDICATE DEVICE MFG TO SPEC.
Description of Event or Problem · 1
IT IS REPORTED THAT THE OUTSIDE PACKAGING WAS INTACT, HOWEVER, THE INNER PACKAGING WAS NOT COMPLETELY SEALED. STERILITY HAD BEEN COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOORE HIP PROSTHESIS LONG FENESTRATED STEM | HIP PROSTHESIS | KWY | ZIMMER MANUFACTURING B.V. | NA | 60039233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |