MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TPR KINECTIV STEM SZ 12.5; PROSTHESIS, HIP

Catalog Number	00771301200
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown head.Uknown cup.Unknown liner.G2: foreign ¿ japan.H6: proposed component code: mechanical (g04) - stem.The reported product remains implanted to date; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported, during the rehabilitation period, the stem subsidence occurred due to a skeletal fracture.It was confirmed that no further information could be provided.
Event or Problem Description
No additional information available for the reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d4; g3; h2; h3; h4; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total hip arthroplasty shows radiographic findings suggesting subsidence of the femoral stem.However, a definitive call of subsidence would require comparison with baseline x-rays.If present, a risk factor for subsidence in this case would be generalized reduced bone mineral density.No fracture is demonstrated on the ap x-ray provided for review.However, evaluation for fracture is limited due to lack of a second radiographic view and lack of baseline x-rays.A definitive root cause cannot be determined.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 trends.

• Brand Name: M/L TPR KINECTIV STEM SZ 12.5
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24481986
• Report Number: 0001822565-2026-00644
• Device Sequence Number: 10331912
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00771301200
• Device Lot Number: 67500593
• 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: 02/07/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Unknown