MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSS REINFORCED YOKE; PROSTHESIS KNEE

Catalog Number	150493
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient is experiencing fractured implant post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: oss poly lock pin catalog # 150478 lot # 66573573, oss tibial poly bearing 14mm catalog # 150411 lot # 65980068, oss rs poly fem bushings set/2 catalog # 161034 lot # 66366660, oss rs axle catalog # 161035 lot # 66602748, oss poly femoral bushings catalog # 150477 lot # 66521413, oss poly tibial bushing catalog # 150476 lot # 65790850, oss cemented im stem 11x150 catalog # 150365 lot # 65712982, oss non-mod tib plate long 71 catalog # 161043 lot # 66509370, oss rs 7 cm ellip seg fmrl-rt catalog # 161009 lot # 66495560.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: a4, b2, b4, b5, b7, d2, d6b, g1, g3, g6, h1, h2, h6.
Event or Problem Description
It was reported patient underwent a revision procedure seven months post implantation due to fractured implant.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d5, d9, g3, h2, h3, h6 the reported event was confirmed via device return.Visual examination of the returned product identified signs of use in the form of surface starches and the tabs (flanges) of the device were found to be broken off.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Further analysis determined the fracture surface artifacts of striations suggest the fatigue mode of failure.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a healthcare professional.Review identified distal femoral implant fracture with maintained alignment of the right knee arthroplasty.The visualized implants are anatomically aligned and there was no evidence of loosening.Bone quality appears osteopenic.A definitive root cause could not 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 for trends.
Event or Problem Description
No additional information to report at this time.

• Brand Name: OSS REINFORCED YOKE
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21292142
• Report Number: 0001825034-2025-00242
• Device Sequence Number: 18086417
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)340415(10)66625642
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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: Lay User/Patient
• Device Catalogue Number: 150493
• Device Lot Number: 66625642
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 06/13/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/24/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 55 KG