ALLOCLASSIC OFFSET STEM 3
Received Feb 26, 2013 · Event occurred Feb 15, 2013
Report 9613350-2013-01375 · MDR key 2989705
Device
Generic name
Modification To Alloclassic Zweymuller
Manufacturer
Zimmer GmbhCatalog number
0100121030
Lot number
2397963
Product problems
- Device Expiration Issue
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALLOCLASSIC OFFSET STEM 3 ON (B)(6) 2013. THE PATIENT NOTICED THAT THE STERILIZATION EXPIRATION DATE WAS EXPIRED.
Additional Manufacturer Narrative
AN INVESTIGATION OF THE DOCUMENTS PROVIDED REVEALED THAT THE ZIMMER PRODUCT WAS IMPLANTED AFTER THE STERILIZATION DATE OF THE IMPLANT HAS EXPIRED. THIS SITUATION REFLECTS AN OFF LABEL USE. THE USE OF A PRODUCT AFTER EXPIRATION DATE IS NOT APPROVED AND RECOMMENDED BY ZIMMER AT ALL. ZIMMER (B)(4)CONSIDERS THIS CASE AS CLOSED. (B)(4).