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

Model Number	00-5878-065-32
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation in progress.
Event or Problem Description
It was reported that patient underwent right total knee arthroplasty and subsequently is experiencing a crackling noise, pain, swelling and difficulty ambulating.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed as no medical records were received.Review of the device history records identified no related deviations or anomalies during manufacturing.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION TM STANDARD PRIMARY PATELLA
• Common Device Name: TM PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9079313
• Report Number: 3005751028-2019-00030
• Device Sequence Number: 2762899
• Product Code: JWH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)220430(10)63650151
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 00-5878-065-32
• Device Catalogue Number: 00587806532
• Device Lot Number: 63650151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 84