MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 will be submitted.
Event or Problem Description
It was reported, that the patient underwent a left knee revision.Approximately 5.5 years post implantation, due to a fractured tibial plate.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: sizing is appropriate.Left total knee arthroplasty with possible loosening of the tibial component and curvilinear metallic fragment within (b)(6)'s fat concerning for fractured hardware.A definitive root cause cannot be determined.Complaint is confirmed with the provided radiographs.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3; b4; b5; d6b; g2; g3; g6; h1; h2; h11.B3: event date - march 2024: d6b: explant date - march 2024.This additional information does not change the investigation.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 the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b3; b4; b5; d6b; g3; g6; h1; h2; h6.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, the patient developed pain, swelling, and there was concern for prosthesis failure on radiograph.The patient was revised with placement of competitor product approximately 5 years and 3 months post implantation.The initial patella was retained.Intra-operative findings included scar tissue, significant poly wear, and metallosis.No further details have been provided at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10; h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision operative notes: mechanical loosening of left knee prosthetic joint and metallosis.Patient presents with pain and swelling of l knee and evidence of prosthesis failure on radiographs.The knee was entered and metallosis was immediately identified throughout the entire capsule and resected.The tibia was then entered at the bone prosthesis interface with a combination of standard and thin osteotomes circumferentially.The tibia was found to be grossly stable, but significant posterolateral poly and metal wear was identified as the source of the metallosis.The femur was entered with osteotomes circumferentially at the prosthesis cement interface.The femur did not appear grossly loose.The femur was extracted with minimal bone loss after meticulous dissection.A definitive root cause cannot be determined.Complaint is confirmed with the provided medical records.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: TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 19038176
• Report Number: 3007963827-2024-00102
• Device Sequence Number: 6986159
• Product Code: MBH
• UDI-Device Identifier: 00889024471078
• UDI-Public: (01)00889024471078(17)280630(10)64071837
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/05/2025

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: 42532007501
• Device Lot Number: 64071837
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 03/27/2025; 04/03/2024; 09/04/2025
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 08/01/2024; 04/15/2025; 04/22/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Male