MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP T1 PPS 13X111MM 111MM T1; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during incoming inspection, the inner pouch was found to be torn.No adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Foreign: 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: 0001825034-2022-01529, 0001825034-2022-01532.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Evaluation of the returned products confirmed damage to the sterile packaging pouch, and there is debris inside the sterile packaging which is consistent with the appearance of porous coating.Sterility has not been compromised as the outer sterile barrier is intact.The reported event is confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the products when they left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.This event is no longer considered a reportable event.A corrective action has been opened to investigation this event further.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 available at the time of this report.

• Brand Name: TPRLC XR MP T1 PPS 13X111MM 111MM T1
• 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: 14880311
• Report Number: 0001825034-2022-01531
• Device Sequence Number: 17688950
• Product Code: LPH
• UDI-Device Identifier: 00880304517325
• UDI-Public: (01)00880304517325(17)281222(10)6450937
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 51-145130
• Device Lot Number: 6450937
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2018
• 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