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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: femur trabecular metal cruciate retaining (cr) standard porous catalog#: 42502806401 lot#: 64635133; articular surface fixed bearing cruciate retaining (cr) left 10 mm height catalog#: 42502806401 lot#: 64635133.The device will not be returned for analysis, as its current location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately four months post-implantation due to tibial loosening.No bone in growth was seen on the explanted tibia component.No further information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photograph.Visual examination of the provided picture identified evidence of being implanted and a fractured peg.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.
Event or Problem Description
It was reported that patient underwent a left knee revision approximately four months post-implantation due to tibial loosening.No bone in growth was seen on the explanted tibia component.The bone had noted osteosclerosis.The tibial tray peg fractured during removal.

• Brand Name: NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING LEFT SIZE F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11453405
• Report Number: 0001822565-2021-00651
• Device Sequence Number: 3522997
• Product Code: MBH
• UDI-Device Identifier: 00889024510579
• UDI-Public: (01)00889024510579(17)290531(10)64193713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007501
• Device Lot Number: 64193713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other