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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
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 was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a knee procedure.Subsequently, the patient was revised one year post procedure due to hot ct scan.Tm patella hot (loose) on ct scan - removed and replaced with cemented patella.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: no product was returned; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Medical records were not provided.A field action search identified no quality hold with an r-code as the reason associated with the part/lot combination.The complaint is not confirmed.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
It was reported the patient underwent a knee procedure.Subsequently, the patient was revised one year post procedure due to hot ct scan.The patella was removed and replaced with cemented patella.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STD PRIMARY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14944592
• Report Number: 3005751028-2022-00019
• Device Sequence Number: 14598164
• Product Code: JWH
• UDI-Device Identifier: 00889024309814
• UDI-Public: (01)00889024309814(17)251024(10)64850866
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 10/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 00587806535
• Device Lot Number: 64850866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2022
• 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 Sex: Unknown