MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 13X146MM MM T1; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source, foreign: (b)(6).The event was confirmed with product received.Upon visual evaluation, there was damage to the sterile blister and pouch with debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating.Sterility has been compromised.Device history record was reviewed and no discrepancies relevant to the reported event were found.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 and a packaging design issue.A corrective action was previously opened to address this complaint.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.
Event or Problem Description
It was reported that during an inspection of inventory in the warehouse, debris in the sterile packaging was found.Upon further inspection by the manufacturer, there was damage to sterile blister and pouch with debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging and the porous coating.Sterility has been compromised.There was no patient involvement and no adverse consequences were reported.No further event information available at the time of this report.

• Brand Name: TPRLC XR T1 PPS 13X146MM MM T1
• Common Device Name: 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: 12758018
• Report Number: 0001825034-2021-03058
• Device Sequence Number: 14288621
• Product Code: LPH
• UDI-Device Identifier: 00880304517141
• UDI-Public: (01)00880304517141(17)290610(10)6561978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-105130
• Device Lot Number: 6561978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown