MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 15X150MM; PROSTHESIS, HIP

Catalog Number	51-104150
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inspecting the packaging, the sterile packaging was found damaged.There was no patient involvement.There is no further information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: 51-104120 item name tprlc 133 t1 pps ho 12x144mm lot# 7004917; d10: 51-109050 item name tloc 133 mp sp t1 pps ho 5x95 lot # 7224177; d10: 51-145170 item name tprlc xr mp t1 pps 17x119mm lot # 7338366; d10: 51-104140 item name tprlc 133 t1 pps ho 14x148mm lot # 6289615; d10: 51-107160 item name tprlc 133 mp type1 pps ho 16.0 lot # 7124269.G2: 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.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h6; h10.Visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister).Sterility has not been compromised.The reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.The root cause of the reported event can be attributed to transit damage and a packaging design issue.The reported event has been confirmed by evaluation of the provided photos/returned product.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 133 T1 PPS HO 15X150MM
• 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: 22140081
• Report Number: 0001825034-2025-01576
• Device Sequence Number: 12527805
• Product Code: KWA
• UDI-Device Identifier: 00880304489776
• UDI-Public: (01)00880304489776(17)270420(10)6032531
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101086
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 51-104150
• Device Lot Number: 6032531
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE H11
• Patient Sex: Unknown