MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 FP TYPE1 PPS HO 6.0; PROSTHESIS, HIP

Catalog Number	51-101060
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	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 51-100050 item name tprlc 133 fp type1 pps so 5.0 lot # 7255853.51-103170 item name tprlc 133 t1 pps so 17x154mm lot # 6700397.51-101050 item name tprlc 133 fp type1 pps ho 5.0 lot # 7178386.51-103150 item name tprlc 133 t1 pps so 15x150mm lot # 7462705.51-100050 item name tprlc 133 fp type1 pps so 5.0 lot # 7481579.51-103200 item name tprlc 133 t1 pps so 20x160mm lot # 6429500.51-103170 item name tprlc 133 t1 pps so 17x154mm lot # 7089384.51-101050 item name tprlc 133 fp type1 pps ho 5.0 # lot # 7194487.51-100040 item name tprlc 133 fp type1 pps so 4.0 lot # 7650217.51-100050 item name tprlc 133 fp type1 pps so 5.0 lot # 7508981.51-100040 item name tprlc 133 fp type1 pps so 4.0 lot # 7378161.The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the stem punctured the interior packaging resulting in a loss of sterility.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2025-00294.0001825034-2025-00295.0001825034-2025-00296.0001825034-2025-00298.0001825034-2025-00299.0001825034-2025-00300.Visual examination of the returned product/provided photos identified damage to the sterile packaging (blister and/or pouch).Sterility has been compromised.The complaint was confirmed based on the evaluation of the returned product and 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
No additional event information to report at this time.

• Brand Name: TPRLC 133 FP TYPE1 PPS HO 6.0
• 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: 21332480
• Report Number: 0001825034-2025-00297
• Device Sequence Number: 8457296
• Product Code: KWA
• UDI-Device Identifier: 00880304499072
• UDI-Public: (01)00880304499072(17)311217(10)7161459
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 51-101060
• Device Lot Number: 7161459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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: Female