MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 18X156MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stem was opened, and the packaging showed signs of wear.The surgeon decided not to implant.No additional information on the reported event.
Additional Manufacturer Narrative
(b)(4).Evaluation of the returned product confirmed there is white debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.There is debris inside the sterile packaging which is consistent with the appearance of porous coating.Identified damage to the sterile packaging (pouch).Sterility cannot be confirmed as the blister package was opened upon arrival.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The likely 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 18X156MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15732496
• Report Number: 0001825034-2022-02494
• Device Sequence Number: 15339138
• Product Code: LPH
• UDI-Device Identifier: 00880304517196
• UDI-Public: (01)00880304517196(17)260302(10)3739614
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-105180
• Device Lot Number: 3739614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2016
• 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: NI
• Patient Sequence Number: 1
• Patient Sex: Unknown