MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL LEFT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2- (b)(6).H3- customer has indicated that the product will be returned to zimmer biomet for investigation.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 a patient was revised approximately one month post implantation due to tibial loosening and bone fracture.Postoperatively, the patient's tibia medial bone fractured, and the tibial component was loosening.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b1, b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, and h10 visual examination of the returned product identified signs of being implanted (scratched/nicked) along with foreign material on the distal surface of the implant.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: pre-revision images demonstrate a fracture of the medial tibial plateau with involvement of the medial portion of the tibial component.Loosening not well seen.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received 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
No further event information available at the time of this report.

• Brand Name: NATURAL TIBIA TRABECULAR METAL LEFT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17220506
• Report Number: 0001822565-2023-01718
• Device Sequence Number: 14209053
• Product Code: MBH
• UDI-Device Identifier: 00889024510555
• UDI-Public: (01)00889024510555(17)320308(10)65314650
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 42530007101
• Device Lot Number: 65314650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown