TAPERLOC 133 T1 PPS HO 11X142MM 2MM T1
Received Jan 10, 2020 · Event occurred Dec 23, 2019
Report 0001825034-2020-00166 · MDR key 9574256
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
51-104110
Lot number
3791128
Product problems
- Packaging Problem
- Packaging Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Description of Event or Problem
UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Additional Manufacturer Narrative
(B)(4). (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED WHILE REVIEWING ITEMS AT THE DISTRIBUTORSHIP, THE INNER STERILE POUCH WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.