MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 approximately 22 months post implantation, the patient was revised due to fracturing of the patellar implant.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.The reported event was able to be confirmed by visual examination of the returned product.Visual examination identified fiber-metal pad had fractured.The patella exhibits signs of nicks and gouges, likely from removal.There does not appear to be any bone in the tm substrate.Further analysis determined that the fractured trabecular metal surface did not reveal any fracture artifacts that could characterize the mode of failure.The fractured region on the tm surface of the patella sample showed excessive smearing and debris in the adjacent pores.Eds semi-quantitative elemental analysis showed the elemental composition was consistent with tm.Review of the device history records did not identify any deviations or anomalies during manufacturing.A definitive 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9475149
• Report Number: 3005751028-2019-00044
• Device Sequence Number: 2903263
• Product Code: MBH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K031462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00587806532
• Device Lot Number: 63703532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 05/26/2020
• 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: Hospitalization; Required Intervention