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

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#: 42502206802; femur trabecular metal (cr) narrow porous; lot#: unknown; item#: 42540200032; all-poly patella cemented 32 mm diameter; lot#: unknown; item#: 42522100511; articular surface medial congruent (mc) right 11mm; lot#: unknown.Foreign : (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right knee arthroplasty approximately 17 months ago.At patient's 12 month post-surgery follow up appointment, subsidence was noted on the medial side.A revision will be needed.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right knee arthroplasty approximately 18 months ago.At patient's 12 month post-surgery follow up, subsidence was noted on the medial side.Subsequently, the patient underwent a revision last month.Femoral component and patella remain implanted.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The surgeon states that the patient was revised secondary to osteoporotic changes that occurred after the initial tka.As the complication appears to be due to underlying comorbidities rather than fault of device, it can be deemed not reportable.

Event Description

Initial right total knee arthroplasty on (b)(6)-2020.Subsequently, the patient was revised (b)(6) 2021.The tibial insert was noted to have subsided approximately 6mm into the anteromedial corner of the tibia.According to the surgeon, this was likely secondary to the osteoporosis following the previous tkr.The femoral component was stable as was the patellar component.The femur was noted to be subluxed posteriorly.The femur and patella were stable and left in place, the tibia was revised without complication.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE F
• 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: 12892826
• MDR Text Key: 281402691
• Report Number: 0001822565-2021-03420
• Device Sequence Number: 1
• Product Code: MBH
• 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
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007502
• Device Lot Number: 64140909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 78 KG