FDA Adverse Event
Malfunction
Summary report: N
BIGLIANI/FLATOW OFFSET HUMERAL HEAD
MDR report key: 3002378
·
Received March 7, 2013
Report
- Report Number
- 1822565-2013-00455
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- January 31, 2013
- Report Date
- February 8, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- HSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: AS RETURNED, THE OUTER PACKAGING IS IN SUBSTANDARD CONDITION AND LOOKS AS IF IT WAS DROPPED SEVERAL TIMES. THE INNER CAVITIES ARE DAMAGED IN A MANNER CONSISTENT WITH MISHANDLING. THE HEAD MAY HAVE BEEN SHIPPED MULTIPLE TIMES. BASED ON THE DAMAGE TO THE OUTER PACKAGING THE MOST LIKELY CAUSE OF THE REPORTED CAVITY FAILURE IS THE DEVICE EXPERIENCING GREATER THAN ANTICIPATED LOADS DURING DISTRIBUTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: DEVICE RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION.
Description of Event or Problem · 1
IT IS REPORTED THAT THE INNER PLASTIC CAVITIES WERE YELLOWED AND HAD CRACKS ON BOTH THE OUTSIDE AND INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98358 | BIGLIANI/FLATOW OFFSET HUMERAL HEAD | HSD | ZIMMER, INC. | 60044711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |