MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL FEMORAL DIAPHYSEAL CONE, 30MM, SMALL, LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: trabecular metal femoral diaphyseal cone, 30mm, large, left item# 00545001930 lot# 63024027.
Event or Problem Description
It was reported that patient is experiencing femoral loosening approximately nine months post-implantation.A revision procedure has been scheduled.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing for the part/lot combinations (00545001730/64308845).Review of complaint history found no additional related issues for this item and the reported part/lot (00545001730/64308845) combination.Medical records were not provided.A definitive root cause cannot be determined.
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/corrected updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Investigation reopened upon receipt of medical images.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: five views of the left thigh and knee demonstrate a left total knee arthroplasty with hinged prosthesis and long stem femoral component.Distal femoral resection with long stem left total knee arthroplasty.No definite evidence for loosening but there is rotation of the femur with respect to the tibial component.Ossific density involving the distal aspect of the left femur laterally is presumably postsurgical.No significant radiolucency.Suggestion of a large joint effusion.Rotation of the femoral component with respect to the tibial component without definite evidence for loosening suggesting malposition.Distal femoral resection is present.Osteopenia.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL FEMORAL DIAPHYSEAL CONE, 30MM, SMALL, LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10456648
• Report Number: 3005751028-2020-00075
• Device Sequence Number: 3656560
• Product Code: JWH
• UDI-Device Identifier: 00889024308381
• UDI-Public: (01)00889024308381
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K103517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00545001730
• Device Lot Number: 64308845
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 03/03/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/28/2020; 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention