MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL POSTERIOR MONOBLOCK TIBIA: YELLOW, SIZE 4 E-F 10MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	06/29/2021
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.
Event or Problem Description
It was reported that patient underwent right total knee arthroplasty.The patient was progressing well until the two year follow up when she reported severe pain, restricted adls, and dissatisfaction.The patient completed the study per protocol without intervention one year 4 months post procedure.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.No product was returned; visual and dimensional evaluations could not be performed.The device history records were reviewed for deviations and/or anomalies.No devistions related to the event were found.Insufficient information provided, unable to perform a compatibility check.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: @6 weeks, severe lateral joint line pain, mild posterior pain.Daily gabapentin, no instability, rom 0-115*.Moderate pain, moderate trouble, limping all the time.Somewhat satisfied.@1 year, mild global pain, prn otc meds, no instability, rom 0-125*, moderate pain and difficulties, somewhat satisfied.@2 year, severe pain posterior lateral region, daily nsaids.No instability, rom 0-125*.Moderate-extreme difficulty, mostly inactive, restricted adls, very dissatisfied.Completed study per protocol.@2.5 year ae left tka (contralateral) a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL POSTERIOR MONOBLOCK TIBIA: YELLOW, SIZE 4 E-F 10MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 12232670
• Report Number: 3005751028-2021-00056
• Device Sequence Number: 4447692
• Product Code: JWH
• UDI-Device Identifier: 00889024310520
• UDI-Public: (01)00889024310520(17)221031(10)63704926
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• 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: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588606410
• Device Lot Number: 63704926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/04/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/07/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 107