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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No product was returned; visual and dimensional evaluations could not be performed.Device history records were reviewed for deviations and/ or anomalies with none identified.Insufficient information provided.Unable to perform a compatibility check.Medical records were not provided.Images were provided and assessed: left total knee arthroplasty with fracture of the patellar implant with fractured portion in the suprapatellar bursa as well as multiple tiny metallic fragments throughout the joint space.Moderate joint effusion.Fracture of the patellar implant with fractured portion in the suprapatellar bursa as well as multiple tiny metallic fragments throughout the joint space.No evidence for trauma.There is a suprapatellar bursa which could possibly relate to trauma but could also relate to the fractured hardware.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
It was reported that approximately 5 years post implantation, the patient underwent a left knee revision due to the patella becoming loose and sheared off.A new zimmer cemented patella was implanted.No additional information available at this time.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STANDARD PRIMARY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 12569717
• Report Number: 3005751028-2021-00060
• Device Sequence Number: 19846997
• Product Code: JWH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)210531(10)63356267
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K011904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00587806532
• Device Lot Number: 63356267
• 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: 09/09/2021
• Initial Report FDA Received Date: 10/04/2021
• 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 Age: 48 YR
• Patient Weight: 109