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

Catalog Number	00811400230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip revision approximately 10 years post implantation due to a periprosthetic fracture.No further details or outcomes provided.It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
(b)(4).D10: biolox delta ceramic taper liner, size ll / 36 i.D.For use with 58 mm o.D.Size ll shell item: 00877501336, lot: 2794553.58mm o.D.Size ll porous uncemented with cluster holes shell use with ll liners item: 00875705801, lot: 2794553.Biolox delta, ceramic femoral head, l, 36/+3.5, taper 12/14 item: 00877503603, lot: 2794553.Allen medullary cement plugs 1-24 mm diameter flange/12 mm diameter core store in cool dry place item: 00801102024, lot: 63039064.G2: foreign ¿ australia.H6: suggested component code: mechanical (g04) ¿ stem.The customer indicated that the product location is unknown; therefore, it will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h3; 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 not provided.Review of the information in the per by a health care professional identified: femoral stem revision for periprosthetic fracture.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic spiral fracture of the proximal femur, coincident with mid-distal femoral stem.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.
Event or Problem Description
No additional information available for the reported event.

• 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: 23789907
• Report Number: 0001822565-2025-04483
• Device Sequence Number: 17535464
• Product Code: JDI
• UDI-Device Identifier: 00889024145801
• UDI-Public: (01)00889024145801(17)250430(10)63027453
• 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: 2015
• 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): 12/19/2025

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 00811400230
• Device Lot Number: 63027453
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2015
• 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
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG