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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 07/14/2020

Event Type  Injury  

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 and mdrs: 00588605412 trabecular metal posterior stabilized monoblock tibial component: size 4, 12mm lot# 62970214.Mdr: 3005751028-2021-00005.

Event Description

It was reported the patient underwent a right tka.Subsequently, approximately one year, five months later it was noted the patient is dissatisfied with the outcome of the knee.As well as experiencing moderate to severe pain.Pain medications were prescribed and noted as tolerated.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: notes pain as severe by patient; able to ambulate on 5-15 mins with no assistive devices.Moderate pain, on gabapentin.Notes very dissatisfied with outcomes with knee and pain.Office notes confirms reported fall onto right knee in march.States has burning sensation over lateral knee, mostly at night, pain rates at 6, swelling of bilateral feet and right calf pain and pain when compressed, worse with activity, states feels like gives out with prolonged walking or standing.Minimal swelling noted during exam, rom 5to110, incision healed no redness, or bruising or drainage.It was reported patient fell; however the cause of fall is unknow.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STANDARD PRIMARY PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 11313742
• MDR Text Key: 231366587
• Report Number: 3005751028-2021-00006
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)240229(10)64227884
• Combination Product (y/n): N
• PMA/PMN Number: K011904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00587806532
• Device Lot Number: 64227884
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 85