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

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Associated products : item#: 42512400912; articular surface fixed bearing (ps) left 12 mm height; lot#: 63923349.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it's 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 a patient underwent an initial left knee arthroplasty approximately 2 years ago.Subsequently, while performing a revision of a persona tm femur, tibia and patella for flexion instability, the surgeon noticed that the tm tibia was loose.Tibia and articular surface were removed.Patella and femoral component remain in patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified a two peg tibial tray with foreign material on its pegs and inferior surface.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revised due to instability; found patella and femoral component well-fixed and stable, patella tracked well; tibial component found grossly unstable and loose, easily extracted and was found contained in cavitary defect anteromedial; changed to stemmed tibia/cemented; posterior capsule release off femur to address flexion gap; no complications.A definitive root cause cannot be determined.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.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE G
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12198929
• MDR Text Key: 262550339
• Report Number: 0001822565-2021-02026
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024510593
• UDI-Public: (01)00889024510593(11)200331(10)64140980
• Combination Product (y/n): N
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007901
• Device Lot Number: 64140980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 113