MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 14X148MM MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that the inner packaging was damaged and deemed unsterile.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The reported event is confirmed.As the sterile blister was not returned and cannot be evaluated, the sterility, or breach thereof, cannot be confirmed.Visual evaluation of the returned product found the sterile pouch exhibits creasing and holes with black debris/stain from the porous coating as a result of the implant shifting in the sterile packaging during transit.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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.

• Brand Name: TPRLC XR T1 PPS 14X148MM MM T1
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13712205
• MDR Text Key: 287206882
• Report Number: 0001825034-2022-00527
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304517158
• UDI-Public: (01)00880304517158(17)280408(10)6238840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-105140
• Device Lot Number: 6238840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1