MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER STD; PROSTHESIS, HIP

Catalog Number	00811400300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Periprosthetic fracture (4902)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.H6: proposed component code: mechanical (g04) - stem.The product was requested but was not returned by the hospital and will therefore not be sent to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision of competitor products due to a mssa infection.During the procedure an anterolateral cortical breach occurred while attempting to remove the competitor¿s distal cement mantle, creating a propagated fracture.A zimmer biomet total hip arthroplasty was implanted, and the patient was discharged on 25 percent touch weight bearing restrictions and three months of antibiotic therapy.Approximately one month later, while swinging the patient¿s legs into bed, felt a crack and developed pain.Subsequently, the patient underwent a revision where all products were revised, and cerclage cables were implanted to secure the fracture site.No further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: 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 record(s) identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: zb products implanted during active infection: swinging legs into bed and felt a crack.Had pain since, no falls.The patient had a pre-existing, untreated fracture during the removal of competitor products 1-month prior.Radiographs were provided and reviewed by a health care professional.Single ct slice was not submitted to radiology review as the allegations were confirmed in the medical notes.A definitive root cause cannot be determined.It is unknown if during the previous revision to remove the competitor distal cement mantle, creating a propagated fracture, caused or contributed to the reported event.As per ifu 87-6203-912-99, use of this device is contraindicated in patients with active infection at sites such as the genitourinary tract, pulmonary system, skin, or other sites because hematogenous spread may occur.The foci of infection must be treated and the infection resolved prior to surgery.This device was implanted during an active infection which is considered off-label use of the device.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.
Event or Problem Description
Due diligence is complete as multiple attempts were made; however, no further information is available.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER STD
• 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: 23553489
• Report Number: 0001822565-2025-04125
• Device Sequence Number: 15783461
• Product Code: JDI
• UDI-Device Identifier: 00889024145818
• UDI-Public: (01)00889024145818(17)310914(10)65061345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00811400300
• Device Lot Number: 65061345
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 49 KG