MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE D; PROSTHESIS, KNEE

Model Number	42-5300-067-02
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Cramp(s) /Muscle Spasm(s) (4521); Muscle/Tendon Damage (4532)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: femur trabecular metal cruciate retaining (cr) narrow porous: catalog#42502206602, lot#ni; articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 8-9: catalog#42522100511, lot#ni.Report source: foreign: (b)(6).Customer 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 a patient underwent an initial right knee total arthroplasty.Subsequently, the patient began experiencing ongoing hamstring spasms and contractures.Ten days post-implantation, the patient underwent revision surgery and the anterior aspect of the tibia was found to be progressively subsiding.All components were exchanged.Attempts have been made and no further information has been provided at the time of this report.
Event or Problem Description
It was reported that a patient underwent an initial right knee total arthroplasty.Subsequently, the patient began experiencing ongoing hamstring spasms and contractures.Ten days post-implantation, the patient underwent revision surgery and the anterior aspect of the tibia was found to be progressively subsiding.During the revision, the surgeon noted that the tibial component was loose and subsided due to collapse of the anterior aspect of the tibial bone under extension load.Additionally, the patellar tendon insertion had avulsed as a result of the tibial subsidence.All components were exchanged.Attempts have been made and no further information has been provided 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 is complete, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the tibial component was loose and subsided, but the femoral component was stable, the bone was not strong enough to support the anchor, the x-rays were not sent for review as the revision notes provide sufficient dictation of findings.Root cause was unable to be determined, though poor bone quality was a contributing factor.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; d10; g3; h2; h4; h10.D10: medical product: femur trabecular metal cruciate retaining (cr) narrow porous: catalog#42502206602, lot#64947223; articular surface medial congruent (mc) right 11 mm height use with tibia sizes c-d/cr femur sizes 8-9: catalog#42522100511, lot#65017201.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE D
• 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: 13861837
• Report Number: 0001822565-2022-00818
• Device Sequence Number: 5345843
• Product Code: MBH
• UDI-Device Identifier: 00889024510548
• UDI-Public: (01)00889024510548(17)310310(10)64883756
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/08/2022

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 Model Number: 42-5300-067-02
• Device Catalogue Number: 42530006702
• Device Lot Number: 64883756
• 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: 02/25/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 05/15/2022; 06/27/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/19/2022; 05/20/2022; 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female