MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STANDARD PRIMARY PATELLA; 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); Burning Sensation (2146); Swelling/ Edema (4577)
Date of Event	07/14/2020
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.Additional associated products and mdrs: 00588605412 trabecular metal posterior stabilized monoblock tibial component: size 4, 12mm lot# 62970214.Mdr: 3005751028-2021-00005.
Event or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 11313742
• Report Number: 3005751028-2021-00006
• Device Sequence Number: 2660812
• Product Code: JWH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)240229(10)64227884
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/19/2021
• 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: 85