MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00588604510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part# (b)(4), lot# 63994896.No devices or photos were received; therefore the condition of the components is unknown.No compatibility issues were noted.No medical records were provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause cannot be determined.If any further information 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
It was reported that the patient underwent initial knee arthroplasty on approximately 19 months ago.Subsequently, the patient was revised due to pain and stiffness on approximately 6 months post-implantation.This revision was for resurfacing of patient¿s natural patella and lateral release.

• Brand Name: TRABECULAR METAL CRUCIATE RETAINING MONOBLOCK TIBIAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 10006005
• Report Number: 3005751028-2020-00051
• Device Sequence Number: 10948145
• Product Code: MBH
• UDI-Device Identifier: 00889024310087
• UDI-Public: (01)00889024310087
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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: 03/31/2023
• Device Catalogue Number: 00588604510
• Device Lot Number: 63935774
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2019
• Initial Report FDA Received Date: 04/28/2020
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention