FDA Adverse Event
Malfunction
Summary report: N
ZIMMER REVERSE SHOULDER HUMERAL STEM
MDR report key: 2150572
·
Received June 22, 2011
Report
- Report Number
- 1822565-2011-01478
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 27, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: THE LID WAS NOT RETURNED FOR EVAL DUE TO CONTAMINATION; IT WAS DISCARDED IN THE FIELD. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. NO OTHER COMPLAINTS OF ANY TYPE HAVE BEEN RECEIVED FOR THIS LOT. WITH THE INFO PROVIDED, AN EXACT CAUSE FOR THE REPORTED PUNCTURE CANNOT BE DETERMINED. AS RETURNED, THE REMAINDER OF THE PACKAGING MATERIAL IS INTACT. THE MATERIAL IS IN GOOD SHAPE AND DOES NOT INDICATE MISHANDLING. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HUMERAL STEM'S INNER SEAL WAS PUNCTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER REVERSE SHOULDER HUMERAL STEM | HSD | ZIMMER, INC. | 61660099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |