TPRLC 133 T1 PPS HO 16X152MM 2MM T1
Received Jan 9, 2020 · Event occurred Dec 17, 2019
Report 0001825034-2020-00155 · MDR key 9568539
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
51-104160
Lot number
2548615
Product problems
- Tear, Rip or Hole in Device Packaging
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). FOREIGN COUNTRY: (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-00154. 0001825034-2020-00155. 0001825034-2020-00156.
Description of Event or Problem
IT WAS REPORTED THE WAREHOUSE INVESTIGATED AND CIRCULATED ITEMS AND IDENTIFIED INNER POUCHES DAMAGED. NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
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.