MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR FP TYPE1 PPS 4X128MM; PROSTHESIS, HIPS

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	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the circulated items were inspected and that the inner pouch was found to be damaged.There was no patient involvement.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: 51-145160 tprlc xr mp t1 pps 16x117mm 3684183.51-107150 tprlc 133 mp type1 pps ho 15.0 7024048.51-103170 tprlc 133 t1 pps so 17x154mm 6103542.51-105130 tprlc xr t1 pps 13x146mm 7136705.51-109050 tloc 133 mp sp t1 pps ho 5x95 7224177.51-104090 tprlc 133 t1 pps ho 9x137mm 6934291.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10, h11.Visual evaluation of the provided photos identified damage to the sterile packaging (pouch).Sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported event can be attributed to transit damage and a packaging design issue.This complaint has been confirmed by evaluation of the provided photos.A complaint history search was not performed as the packaging design has been remediated as a part of corrective action.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11 the reported event was confirmed by review of the suspected product.Visual evaluation of the returned product identified damage to the sterile packaging (pouch).Sterility has been compromised.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A complaint history search was not performed as the packaging design has been remediated.The root cause of the reported event can be attributed to transit damage and a packaging design issue.Corrective actions have been previously raised to implement improved packaging changes.These packaging changes will reduce the number of transit related packaging damage events.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information.

• Brand Name: TPRLC XR FP TYPE1 PPS 4X128MM
• Common Device Name: PROSTHESIS, HIPS
• 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: 22025969
• Report Number: 0001825034-2025-01411
• Device Sequence Number: 9042621
• Product Code: LPH
• UDI-Device Identifier: 00880304516878
• UDI-Public: (01)00880304516878(17)320316(10)7198022
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2026

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 51-102040
• Device Lot Number: 7198022
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 12/31/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/29/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: SEE H11 NARRATIVE.
• Patient Sex: Unknown