MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 4; PROSTHESIS, KNEE

Model Number	5986-37-01
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Subluxation (4525); Swelling/ Edema (4577)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total right knee arthroplasty.Subsequently, four (4) years post-implantation, the patient presented with increased pain, swelling, and difficulty ambulating due to a fractured tibial component with subluxation.The patient underwent revision surgery of all components without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: medical product: articular surface regular constraint size yellow/c-h 10 mm height: catalog#90597003010, lot#64482990; femoral component precoat size f left: catalog#00575001601, lot#64183394; unknown bone cement: catalog#ni, lot#ni.G2: foreign: finland.The product is in the process of being returned to zimmer biomet for evaluation.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d1; d4; d9; g3; h2; h3; h4; h10.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified sign of use and the tray was fractured on the anterior surface.Device was submitted for further analysis.Analysis found beach marks and fatigue striations, which are consistent with the fatigue failure mode.Material analysis determined that tibial plate was ti6-4 titanium alloy, which was consistent with the print specification.Complaint is confirmed based on product evaluation.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the provided ops note found that patient experienced pain, swelling, difficultly ambulating, walks with two support due to subluxation and fractured tibial component.Initial components were removed without any issue.X-ray was reviewed and review found right total knee arthroplasty with possible polyethylene wear posteriorly as well as anterior subluxation of the tibia.Fracture of the tibial component not well visualized on this study.Root cause was unable to be determined.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: STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17297400
• Report Number: 0002648920-2023-00146
• Device Sequence Number: 3715654
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)280630(10)64085257
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2024

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: 5986-37-01
• Device Catalogue Number: 00598603702
• Device Lot Number: 64085257
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 12/29/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/07/2023; 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female