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

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection of stock, the sterile package was found damaged.No additional information is available.
Additional Manufacturer Narrative
(b)(4).Foreign country: japan.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: 0001825034-2023-00260, 0001825034-2023-00262, 0001825034-2023-00263, 0001825034-2023-00264, 0001825034-2023-00269 and 0001825034-2023-00271.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product was returned and evaluated.A visual evaluation of the returned product identified damage to the sterile packaging (blister).Sterility had not been compromised.Evaluation of the returned product also confirmed there was debris inside the sterile packaging which is consistent with the appearance of porous coating.The reported event was confirmed.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported event was not related to a combination of products; therefore, a compatibility review was not applicable.The condition of the device when it left zimmer biomet was 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: TPRLC XR T1 PPS 13X146MM
• 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: 16352691
• Report Number: 0001825034-2023-00268
• Device Sequence Number: 6824042
• Product Code: LPH
• UDI-Device Identifier: 00880304517141
• UDI-Public: (01)00880304517141(10)300928(17)6866868
• 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): 05/04/2023

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 51-105130
• Device Lot Number: 6866868
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• 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