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

Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); Cramp(s) /Muscle Spasm(s) (4521); Muscle/Tendon Damage (4532)

Event Date 02/25/2022

Event Type  Injury  

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 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 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.

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.

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 Description

No further event information at time of this report.

Event Description

No further event information at time of this report.

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.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE D
• Type of Device: 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
• MDR Text Key: 287691614
• Report Number: 0001822565-2022-00818
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024510548
• UDI-Public: (01)00889024510548(17)310310(10)64883756
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female