MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED 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	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was revised approximately ten months post implantation due to tibial loosening.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
(b)(4).D10- medical product psn femoral tm left sz 10 cr item# 42502206801 lot# 65741598.Psn poly left 10mm mc item# 42512100810 lot# 65763995.Unknown bone cement.G2- australia.H3- customer has indicated that the product will not 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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11.Corrected: h6 clinical code.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided; however, they are not related to this event.The initial procedure records indicate the following details: medial parapatellar approach, patella not resurfaced, robotic assistance, range of motion from 0 to 130 degrees, with no reported complications.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is received which would change or alter any conclusions or information, a supplemental medwatch will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19269265
• Report Number: 3007963827-2024-00172
• Device Sequence Number: 17887778
• Product Code: MBH
• UDI-Device Identifier: 00889024471054
• UDI-Public: (01)00889024471054(17)330326(10)65843912
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 09/06/2024

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: 42532007101
• Device Lot Number: 65843912
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG