MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TRABECULAR METAL STANDARD PRIMARY PATELLA; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unstable (1667); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Aseptic loosening (4883)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona posterior stabilized standard porous femoral component catalog #: 42500806401 lot #: 64553846, persona posterior stabilized articular surface left 12mm catalog #: 42511400712 lot #: 64345805, persona trabecular metal two-peg porous tibial component left size e catalog #: 42530007101 lot #: 64753512.The product has been received by zimmer biomet and 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 that the patient underwent a left knee arthroplasty revision due to the post shearing off the patellar component approximately two (2) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address pain, an audible popping sound and instability secondary to the post shearing off the patellar component approximately two (2) years post-operatively.Attempts have been made, however, no additional information is available.
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.Visual examination of the returned implant confirmed that it had fractured.Optical microscopy and scanning electron microscopy was performed, however, excessive smearing and remaining biological debris on the fracture surface could not identify a definitive failure mode.Radiographs provided were reviewed and previously reported to also confirm patellar implant fracture.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 that the patient underwent a left knee arthroplasty revision to address pain, an audible popping sound, instability and difficulty walking secondary to the post shearing off the patellar component and patellar loosening approximately two (2) years post-operatively.Initial operative notes noted no intraoperative complications.Revision operative notes noted that the patellar component had loss of fixation.The metal component remained attached to the polyethylene component, but there was no apparent bone ingrowth into the trabecular metal portion of the patella.The tibial and femoral components were found to be intact with no issues.The patellar component was revised and a new patellar component was cemented into place without complications.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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 corrected information.The following sections were corrected: b4, g3, g6, h2, h11.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported under manufacturing report number (b)(4).

• Brand Name: NEXGEN TRABECULAR METAL STANDARD PRIMARY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16674520
• Report Number: 0001822565-2023-00912
• Device Sequence Number: 15087865
• Product Code: MBH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)251112(10)64850894
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/21/2025

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: 11/12/2025
• Device Model Number: N/A
• Device Catalogue Number: 00587806532
• Device Lot Number: 64850894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 09/01/2023; 04/17/2025; 07/25/2025
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/18/2023; 09/06/2023; 05/07/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female