MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR T1 PPS 10X140MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the taperloc stem packaging was damaged and looked like it had mold.There is no additional information available at the time of this report.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the taperloc stem packaging was compromised and there seemed to be a moldy substance in the package.The procedure was completed using another implant.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrected: d4: expiration date.Visual evaluation of the provided photos did not identify any damage consistent with mold or wet packaging.The photos do however depict black staining and scuff marks on the pouch.The black staining could easily be mistaken for mold.Sterility has not been breached.A complaint history search was not performed per (b)(4) as the packaging design has been remediated as part of (b)(4).Mold: a definitive root cause or condition of the device when it left zimmer biomet cannot be determined as the provided photo does not clearly depict/confirm the presence of mold.Black debris: 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.Mold: this complaint cannot be confirmed.Black debris: this complaint was confirmed by evaluation of the provided photo.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
There is no update to the prior event description provided.

• Brand Name: TPRLC XR T1 PPS 10X140MM
• Common Device Name: PROSTHETIC, 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: 19392649
• Report Number: 0001825034-2024-01358
• Device Sequence Number: 12499223
• Product Code: LPH
• UDI-Device Identifier: 00880304517110
• UDI-Public: (01)00880304517110(17)260622(10)3817601
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/31/2024

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 Expiration Date: 06/22/2026
• Device Model Number: N/A
• Device Catalogue Number: 51-105100
• Device Lot Number: 3817601
• Was Device Available for Evaluation?: No
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 06/11/2024; 07/26/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/20/2024; 07/02/2024; 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose