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

Model Number	00-5878-065-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation in progress.
Event or Problem Description
It was noted the patient underwent primary right tka on (b)(6) 2019.Subsequently, the patient was noted to have stiffness and decreased rom during 1 month follow-up visit on (b)(6) 2019 and underwent a mua on (b)(6) 2019.
Event or Problem Description
It was reported that approximately 6 weeks post implantation, the patient was noted to have stiffness and decreased range of motion.Subsequently, the patient underwent a manipulation under anesthesia.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 noted that approximately 6 weeks post implantation, the patient required manipulation under anesthesia due to pain and stiffness.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 STANDARD PRIMARY PATELLA
• Common Device Name: NEXGEN TM PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9072781
• Report Number: 3005751028-2019-00029
• Device Sequence Number: 2774690
• Product Code: JWH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)231130(10)64176468
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 11/30/2023
• Device Model Number: 00-5878-065-32
• Device Catalogue Number: 00587806532
• Device Lot Number: 64176468
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 69