MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 04/29/2022

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure seventeen months post implantation due to instability.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).Medical product: articular surface medial congruent (mc) catalog # 42512100514 lot # 64267672, inset all-poly patella cemented 26 mm diameter catalog # 42540200026 lot # 64775962, articular surface medial congruent (mc) left 10 mm height use with tibia sizes c-d/cr femur sizes 8-9 catalog # 42512100510 lot # 64463436, depuy cmw 2 bone cement catalog # 3322-040 lot # 8723770, natural tibia trabecular metal two-peg porous fixed bearing left size d catalog # 42530006701 lot # 64517314.(b)(4).Report source: (b)(6).Multiple mdr reports were filled for this event: 3007963827-2022-00148.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Visual evaluation of the provided pictures identified a femoral and articular surface, both are covered in a foreign material.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR)
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14474716
• MDR Text Key: 292719243
• Report Number: 0001822565-2022-01499
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00889024230774
• UDI-Public: (01)00889024230774(17)290228(10)64259934
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502806401
• Device Lot Number: 64259934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 73 KG