MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION, TM PRIMARY PATELLA

Model Number	00-5878-065-29
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation in progress.
Event or Problem Description
Patient experience sever pain at 6 months post -op.
Event or Problem Description
It was reported that the patient was experiencing pain at 6 months post implantation.There has been no report of medical intervention or revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were reviewed and identified patient had severe pain at 6-month post op visit.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION, TM PRIMARY PATELLA
• Common Device Name: PRIMARY PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8739133
• Report Number: 3005751028-2019-00015
• Device Sequence Number: 16217690
• Product Code: JWH
• UDI-Device Identifier: 00889024465664
• UDI-Public: (01)00889024465664(17)230731(10)64051018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 07/31/2023
• Device Model Number: 00-5878-065-29
• Device Catalogue Number: 00587806529
• Device Lot Number: 64051018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/22/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 90