MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT POROUS UNCEMENTED SIZE D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty.Subsequently, two years later, the patient was revised due to femoral loosening and pain.The femoral component was revised and the poly was also exchanged in good practice.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00595403702 - tibial tray fixed bearing size 4 do not use with articular surface thicknesses greater than 17 mm - 64393956; 00595203010 - articular surface use with plate 3,4 size yellow/c-h 10 mm height - 64569460; 00597206532 - all poly petella standard cemented size 32 mm diameter 8.5 mm thickness - 64600521; 66056768 - palacos r+g fast - 92134834.Report source: foreign country: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6.H6 : suggested component code: mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT POROUS UNCEMENTED SIZE D
• 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: 15976481
• Report Number: 0001822565-2022-03445
• Device Sequence Number: 15177039
• Product Code: MBH
• UDI-Device Identifier: 00889024259560
• UDI-Public: (01)00889024259560(17)250930(10)63111273
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/06/2023

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 65595201401
• Device Lot Number: 63111273
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2015
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female