MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER SEGMENTAL INTERCALARY SEGMENT 65MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - zimmer segmental fluted stem extension 14mm x 130mm catalog #: 00585205014 lot #: 64458371, zimmer segmental fluted stem extension 17mm x 130mm catalog #: 00585205017 lot #: 63223352 g2 - report source - foreign: event occurred in south africa.The complainant 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.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address intercalary segment implant fracture and instability approximately four (4) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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 and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: b5.Visual evaluation of the returned product identified the device exhibited wear, scratches and scuffing consistent with explantation and was confirmed to be fractured at the wall of the female taper.Additional optical microscopy and scanning electron microscopy determined that the fatigue striations suggested fatigue failure.Dimensional analysis determined that the product was conforming to print specifications where measured.Medical records provided also confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 for trends.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address intercalary segment implant fracture, instability and discomfort approximately four (4) years post-operatively.Attempts have been made, however, no additional information is available.

• Brand Name: ZIMMER SEGMENTAL INTERCALARY SEGMENT 65MM
• Common Device Name: PROSTHESIS, KNEE
• 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: 21970756
• Report Number: 0001822565-2025-01267
• Device Sequence Number: 18170683
• Product Code: LZO
• UDI-Device Identifier: 00889024195981
• UDI-Public: (01)00889024195981(17)290228(10)64308183
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K081860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004465
• Device Lot Number: 64308183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 10/07/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/09/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2019
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 114 KG