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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.Subsequently, the patient presented with left knee pain and instability approximately five years postop and underwent a revision surgery.The bearing and bushing kit were revised.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 161094 - oss rs 12mm ls tibial bearing - (b)(6); 150476 - oss poly tibial bushing - (b)(6); 161034 - oss rs poly fem bushings set/2 - (b)(6); 150478 - oss poly lock pin - (b)(6); 161035 - oss rs axle - (b)(6); 150427 - oss tib blk aug 10x71/75 univ - (b)(6); 150427 - oss tib blk aug 10x71/75 univ - (b)(6); 150400 - oss porous im stem 21.5 x 150 - (b)(6); 161041 - oss rs non-mod plt long 71 - (b)(6); 161014 - oss rs 8.5cm ellip seg fmrl-lt - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01779, 0001825034-2023-01780, 0001825034-2023-01781, 0001825034-2023-01782, 0001825034-2023-01783.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified explanted axle, yoke, bushings and bearing.The polyethylene bearing is worn unevenly.The bushings and the bearing also show signs of damage and fracture.It is assumed to be caused by the explanation of the devices but unknown.The yoke had been fractured and the two metal tabs are pictured separated from the yoke.The device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: polyethylene wear, two radio-opaque objects are noted not connected to the implants, bone quality is osteopenic, no evidence of implant loosening.Lateral polyethylene wear with valgus malalignment as noted.This could result in pain/instability.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 further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that the patient reported clunking, instability, and pain and was revised.During the revision, the poly insert was noted to be broken.No intraoperative complications reported.From provided images, the yoke and tibial bushing were also fractured.Attempts have been made and all available information has been provided.
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 information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Visual inspection of the photograph provided confirms that the bearing, tibial bushings and the yoke tabs have fractured.Revision notes provided state that polyethylene insert was noted to be broken and resting anterior to the distal femoral piece.Fragments of polyethylene found scarred into medial capsule and were retrieved with x-ray and the remaining bushings and modular pieces were explanted.Femur and tibia solidly fixed and in appropriate position.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.

• 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: 17452214
• Report Number: 0001825034-2023-01784
• Device Sequence Number: 7383075
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)270326(10)584150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 11/19/2024

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: 150493
• Device Lot Number: 584150
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 05/08/2024; 11/19/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 11/17/2023; 05/22/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2017
• 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 H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 98 KG