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

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Scar Tissue (2060)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#: 00587806535; articular surface medial congruent (mc) right 10 mm ;lot#: 62539460.Item#: 42502806401; femur trabecular metal cruciate retaining (cr) standard porous; lot#: 62388855.Item#: 42511000516; all poly patella cemented 35 mm diameter; lot#:62461382.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty and subsequently 4.5 years later due to tibial loosening and scar tissue.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Reported event was confirmed by review of medical records.Primary surgery notes provided state no intraoperative complications.Revision operative notes state that the tibial component was loose.Significant scar tissue encountered and removed.Femoral and tibial components removed with minimal bone loss.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.A prior capa determined that the likely root cause for the higher than anticipated complaint rate is that the persona tm tibia allows the potential for the tibial implant to sit proud on the resected tibial surface and the persona tm tibia has less initial stability than predicate devices.The root cause of the reported issue is attributed to a design issue.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.

Event Description

No further event information available at the time of this report.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).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: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10356436
• MDR Text Key: 201524715
• Report Number: 0001822565-2020-02769
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530007501
• Device Lot Number: 62365104
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: ZFA 2015-15
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention