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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION TRABECULAR METAL PRIMARY PATELLA PROSTHESIS, KNEE

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ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION TRABECULAR METAL PRIMARY PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Event Date 06/13/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). The reported event was able to be confirmed by visual inspection of the patella, which exhibited signs of being implanted and the post fractured off. A review of the device history records was unable to be performed as lot number was not provided. Medical records and radiographs were provided and reviewed by a hcp. Review of the available records identified a dislodged patellar hardware component which is subluxed inferiorly by approximately half the patella width. The patella hardware is also slightly tilted with the proximal portion positioned posteriorly and the inferior portion tilted anteriorly. This results in likely metal on metal contact between the patella and femoral component. There is small joint effusion. A definitive root cause was unable to be determined. Concomitant medical devices: unknown tibial component catalog #: ni lot #: ni, unknown femoral component catalog #: ni lot #: ni, unknown articular surface catalog #: ni lot #: ni.

 
Event Description

It is reported that the patient underwent a knee arthroplasty revision to address a dislodged patella and infection post-operatively. Attempts have been made and no additional information is available at this time.

 
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Brand NameNEXGEN COMPLETE KNEE SOLUTION TRABECULAR METAL PRIMARY PATELLA
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer (Section G)
ZIMMER TMT
10 pomeroy road
parsippany NJ 07054
Manufacturer Contact
william hara
10 pomeroy road
parsippany, NJ 07054
9735760032
MDR Report Key10550343
MDR Text Key207502213
Report Number3005751028-2020-00081
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 09/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00587806538
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/17/2020 Patient Sequence Number: 1
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