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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure fifteen months post implantation due to pain in knee.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface medial congruent (mc) catalog # 42522100311 lot # 64821566.Natural tibia trabecular metal two-peg porous fixed bearing catalog # 42530006702 lot # 64696346.Nexgenâ® complete knee solution, trabecular metalâ standard primary patella catalog # 00587806532 lot # 65019535.Biomet bc r 1x40 us catalog # 110035368 lot # az50ba2102.Biomet bc r 1x40 us catalog # 110035368 lot # y11baa2101.Customer has indicated that the product will not be returned because requested but not returned by hospital.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2023-00033 & 0001822565-2023-00487.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: mechanical (g04) - femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Radiograph review indicates there is no issues with anatomic alignment, no signs of loosening, wear, radiolucency, bones appear well mineralized, no fracture or dislocation, large suprapatellar joint effusion and edema in hoffa's fat pad.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: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR)
• 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: 16428901
• Report Number: 0001822565-2023-00485
• Device Sequence Number: 2645048
• Product Code: MBH
• UDI-Device Identifier: 00889024470040
• UDI-Public: (01)00889024470040(17)301216(10)64894501
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• 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
• Report Date (Section B): 04/27/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502205802
• Device Lot Number: 64894501
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG