TAPERLOC 133 T1 PPS SO 14X148MM T1
Received Jan 10, 2020 · Event occurred Dec 27, 2019
Report 0001825034-2020-00169 · MDR key 9574257
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
NICatalog number
51-103140
Lot number
3892150
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). UDI#: (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 T1 PPS SO 16X152MM T1, CAT# 51-103160, LOT# 3886526. TPRLC XR MP T1 PPS 13X111MM 111MM T1, CAT# 51-145130, LOT# 3894668. TPRLC 133 MP TYPE1 PPS SO 17.0 1, CAT# 51-106170, LOT# 6037496. 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: 0001825034-2020-00170, 0001825034-2020-00171, 0001825034-2020-00172.
Description of Event or Problem
IT WAS REPORTED DEBRIS WAS IDENTIFIED WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS DISCOVERED AT THE DISTRIBUTOR'S OFFICE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EVALUATION OF THE RETURNED PRODUCT/PHOTOGRAPHS PROVIDED CONFIRMED THERE IS DEBRIS INSIDE THE STERILE PACKAGING WHICH IS CONSISTENT WITH THE APPEARANCE OF FOAM DEBRIS FROM THE FOAM PACKAGING INSIDE THE STERILE BARRIER. THE REPORTED EVENT IS CONFIRMED AND STERILITY OF THE PRODUCT IS INTACT. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE LIKELY CONDITION OF THE PRODUCT WHEN IT LEFT ZIMMER BIOMET WAS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY TO BE DUE TO TRANSIT DAMAGE CAUSING THE FOAM PACKAGING TO BECOME ABRADED AND SHED. THE EVENT IS BEING ADDRESSED THROUGH THE CAPA PROCESS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.