MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPER STEM 20X185MM; PROSTHESIS, HIPS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: (b)(4) femoral body - revision - nitrided - porous cementless 12/14 neck taper extended 46 mm neck offset (b)(6).G2: foreign: australia.Suggested component code- mechanical (g04): stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip arthroplasty and was implanted with zimmer biomet products.Subsequently, the patient was revised due to a stem fracture.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4 (expiration date, udi #), g3, g6, h2, h3, h6, h11.Corrected: h4.The reported event was confirmed by review of pictures.Visual examination of the provided pictures identified the revised proximal body with the head still assembled on and covered in bio debris.A fractured off section of the distal taper stem can be seen stuck inside the proximal body.No other observations could be noted based on the image alone.No product was returned; further visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single ap radiograph of the left hip shows presence of total hip arthroplasty with zmr femoral stem system.The proximal femoral stem exhibits loosening.The femoral taper stem is fractured at the level of the distal cone body.Generalized reduced bone mineral density is a risk factor for femoral stem loosening.Femoral stem loosening is a risk factor for femoral stem fracture.The images were further reviewed for adequate proximal support and determination of whether the fracture or loosening occurred first.It was identified the proximal support is not adequate.The loose proximal component (cone body) is a known risk factor for distal femoral stem taper fracture.However, without prior imaging and sequence of events it cannot be determined whether the fracture or loosening occurred first.A definitive root cause cannot be determined.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: TAPER STEM 20X185MM
• Common Device Name: PROSTHESIS, HIPS
• 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: 23866334
• Report Number: 0001822565-2025-04714
• Device Sequence Number: 17472596
• Product Code: JDI
• UDI-Device Identifier: 00889024160903
• UDI-Public: (01)00889024160903(17)250630(10)63070323
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/09/2026

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 Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00998202018
• Device Lot Number: 63070323
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Unknown