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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 : unknown - unknown oss femoral component - unknown unknown - unknown oss femoral bushings - unknown unknown - unknown oss stem - unknown unknown - unknown oss tibial component - unknown unknown - unknown oss tibial bushings - unknown unknown - unknown oss bearing - unknown unknown - unknown oss axle - unknown unknown - unknown oss lock pin - unknown unknown - unknown oss tibial augment - unknown 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.
Event or Problem Description
It was reported that the patient underwent an initial knee procedure.Subsequently, the patient has undergone a revision surgery on an unknown date due to pain and an unknown implant issue.Attempts have been made and all available information has been provided.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to pain, instability, and a clunking sensation.During the revision is was noted that the yoke had broken, damage to poly insert, as well as scratches noted on components but well fixed.No intraoperative complications noted.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a4; b3; b4; b5; b6; b7; d1; d2; d4; d6; d10; g1; g3; g6; h1; h2; h3; h6.D10 : 161096 - oss rs 16mm ls tibial bearing - 613080.150478 - oss poly lock pin - 65974060.161035 - oss rs axle - 65816741.161034 - oss rs poly fem bushings set/2 - 65795550.150476 - oss poly tibial bushing - 65809070.161014 - oss rs 8.5cm ellip seg fmrl-lt - 419750.161041 - oss rs non-mod plt long 71 - 942080r.150400 - oss porous im stem 21.5 x 150 - 795170.150427 - oss tib blk aug 10x71/75 univ - 126010.150427 - oss tib blk aug 10x71/75 univ - 385370.Unknown - unknown tibial component - unknown.Unknown - unknown femoral component - unknown.Unknown - unknown tibial tm cone component - unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient reported over the months instability and clunking sensation, pain; yoke had broken with 2 metal tabs medially.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: hinged prosthesis left total knee arthroplasty with distal femoral resection.Remnant patellar and hetero topic ossification seen.Fit and alignment of the implants is appropriate.Osteopenia.No loosening or wear is seen.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: 19187019
• Report Number: 0001825034-2024-01074
• Device Sequence Number: 12549732
• Product Code: KRO
• UDI-Device Identifier: 00880304240094
• UDI-Public: (01)00880304240094(17)330427(10)66046464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 66046464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 10/16/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/16/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 99 KG