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

Model Number	42-5300-071-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: articular surface mc right 18 mm, catalog#: 42522100718, lot#: 64591669.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent revision of the tibial component on right knee due to a bone fracture during implant surgery.Prior to revision surgery, the patient was placed in a knee imobilizer but 'never felt right'.Approximately two and half months post implantation, the tibial component was revised to a cemented tibia with a stem.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.A visual inspection of the return item could not be performed as no product was returned nor were pictures provided.Dhr was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: periprosthetic fracture of the medial tibial plateau with tibial implant loosening.Root cause was unable to be determined.Per package insert of products, 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.
Event or Problem Description
No further event information available at time of this report.

• Brand Name: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12488130
• Report Number: 0001822565-2021-02681
• Device Sequence Number: 4081918
• Product Code: MBH
• UDI-Device Identifier: 00889024510562
• UDI-Public: (01)00889024510562(17)291231(10)64407583
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 42-5300-071-02
• Device Catalogue Number: 42530007102
• Device Lot Number: 64407583
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR