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 Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after follow up on a total knee arthroplasty, it was discovered the patient had a tibia bone fracture and the tibial plate was subsiding.The patient was revised approximately two months post implantation; the femur, articular surface, and tibia were replaced.No additional information is available.
Additional Manufacturer Narrative
(b)(4).Associated product: femur item 42502806001 lot 64947129.Articular surface item 42512100710 lot 65178106.Foreign - (b)(6).The device will not be returned for analysis; 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
No additional information was reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No additional information reported.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device history record was reviewed and no discrepancies relevant to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified evidence of a periprosthetic fracture involving the medial tibial plateau extending to involve the medial aspect of the tibial component and the possibility of subsidence of the tibial component.A definitive root cause cannot be determined.Per package insert bone fracture is a known adverse effect of the system.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 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
• 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: 13771422
• Report Number: 0001822565-2022-00725
• Device Sequence Number: 14704413
• Product Code: MBH
• UDI-Device Identifier: 00889024510579
• UDI-Public: (01)00889024510579(17)310719(10)65016945
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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: 65016945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 03/18/2022; 04/07/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 03/24/2022; 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown