MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 11X142MM MM T1; 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	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 - 2022 - 00492 and 0001825034 - 2022 - 00494.
Event or Problem Description
It was reported circulated items were inspected and identified the sterile package was damaged.No patient involvement.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.The initial report was forwarded in error and should be voided.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified damage to the sterile packaging (blister and pouch).Sterility has not been compromised.Reported event has been confirmed.Evaluation of the returned product confirmed there is debris inside the sterile packaging which is consistent with the appearance of porous coating.The reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event for damage can be attributed to transit damage, and a packaging design issue.The root cause of the reported event for black debris is likely to be due to transit damage causing the porous coating to shed from the implant.A corrective action has been initiated for this event.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
Upon reassessment of the reported event, it has been determined that the device sterility has not been compromised.The initial report was forwarded in error and should be voided.

• Brand Name: TPRLC XR T1 PPS 11X142MM 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: 13685197
• Report Number: 0001825034-2022-00493
• Device Sequence Number: 19318636
• Product Code: LPH
• UDI-Device Identifier: 00880304517127
• UDI-Public: (01)00880304517127(17)291007(10)6644444
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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 Model Number: N/A
• Device Catalogue Number: 51-105110
• Device Lot Number: 6644444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2019
• 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