MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TLOC 133 MP SP T1 PPSHO 6X97.5; PROSTHESIS, HIP

Catalog Number	51-109060
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: japan.Visual evaluation of the returned product/provided photos identified damage to the sterile packaging (pouch).Sterility has been compromised.The complaint is confirmed based on the evaluation of the returned product and the provided photos.Dhr was reviewed and no discrepancies related to the reported event were found.The condition of the device when it left zimmer biomet is considered 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
It was reported that during an inspection of the items in circulation, the inner pouch was found to be torn.There was no patient involvement.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TLOC 133 MP SP T1 PPSHO 6X97.5
• 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: 20634624
• Report Number: 0001825034-2024-02623
• Device Sequence Number: 7463736
• Product Code: KWA
• UDI-Device Identifier: 00880304512993
• UDI-Public: (01)00880304512993(17)290725(10)6589366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110400
• 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): 11/07/2024

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 Catalogue Number: 51-109060
• Device Lot Number: 6589366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown