TPRLC 133 T1 PPS SO 14X148MM
Received Dec 23, 2019 · Event occurred Dec 5, 2019
Report 0001825034-2019-05715 · MDR key 9511105
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
51-103140
Lot number
3809818
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
Description of Event or Problem
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Additional Manufacturer Narrative
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Additional Manufacturer Narrative
(B)(4). UDI # (B)(4). FOREIGN 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05715, 0001825034 - 2019 - 05717, 0001825034 - 2019 - 05718.
Description of Event or Problem
IT WAS REPORTED DURING INSPECTION OF THE CIRCULATED ITEMS IN THE WAREHOUSE, IT WAS DISCOVERED INNER STERILE PACKAGES WERE DAMAGED. NO HOSPITALS OR PATIENTS WERE INVOLVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.