MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Degraded (1153); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices: orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 362040, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: ni, orthopedic salvage system rs axle catalog #: 161035 lot #: ni, unknown orthopedic salvage system lock pin catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system rs segmental distal femur catalog #: ni lot #: ni, unknown orthopedic salvage system rs non-modular tibia catalog #: ni lot #: ni.Report source: foreign: (b)(6).The complainant has not yet indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2022-00354, 0001825034-2022-00355.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision to address post-operative fracture of the yoke, damage to the tibial bearing, pain and difficulty ambulating approximately one (1) year 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.D10 - concomitant devices - orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 362040, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: 685770, orthopedic salvage system rs axle catalog #: 161035 lot #: 994120, unknown orthopedic salvage system lock pin catalog #: ni lot #: ni, unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system rs segmental distal femur catalog #: ni lot #: ni, unknown orthopedic salvage system rs non-modular tibia catalog #: ni lot #: ni.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address post-operative fracture of the yoke, damage to the tibial bearing, pain and difficulty ambulating, requiring a cane approximately one (1) year post-operatively.Revision operative notes noted frontal instability and the two lateral metal locking fins of the yoke were broken, which released the hinge and made it unstable.The components were replaced without difficulty and no intraoperative complications were reported.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 - concomitant devices - orthopedic salvage system reinforced yoke catalog #: 150493 lot #: 362040, orthopedic salvage system rs polyethylene femoral bushings catalog #: 161034 lot #: 685770, orthopedic salvage system rs axle catalog #: 161035 lot #: 994120, orthopedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 604320, orthopedic salvage system proximal modular tibial component 9cm catalog #: cp113461 lot #: 493800, orthopedic salvage system diaphyseal segment locking screw set catalog #: 150481 lot #: 065760, orthopedic salvage system polyethylene locking pin catalog #: 150478 lot #: 069270, unknown orthopedic salvage system rs segmental distal femur catalog #: ni lot #: ni.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address post-operative fracture of the yoke, damage to the tibial bearing, pain and difficulty ambulating, requiring a cane approximately one (1) year post-operatively.Initial operative notes noted there were no intraoperative complications placing the components.Revision operative notes noted frontal instability and the two lateral metal locking fins of the yoke were broken, which released the hinge and made it unstable.The components were replaced without difficulty and no intraoperative complications were reported.
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.Visual inspection of the returned tibial bearing showed wear consistent with usage.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.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 20MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13548452
• Report Number: 0001825034-2022-00355
• Device Sequence Number: 17443045
• Product Code: KRO
• UDI-Device Identifier: 00880304554719
• UDI-Public: (01)00880304554719(17)240402(10)967760
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 07/28/2022

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 Expiration Date: 04/02/2024
• Device Model Number: N/A
• Device Catalogue Number: 161098
• Device Lot Number: 967760
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 04/21/2022; 07/19/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 04/08/2022; 05/11/2022; 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2019
• 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
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 80 KG