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

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: australia.D10 - medical product: articular surface medial congruent (mc) catalog # 42522100911 lot # 65447515; all-poly patella cemented catalog # 42540200035 lot # 65915539; tibia trabecular metal two-peg porous fixed bearing catalog # 42530008302 lot # 65462703; patella reamer blade catalog # 00597909535 lot # 65841818; 2.5 mm female hex screw catalog # 42509902525 lot # 65987354; rosa knee single use kit catalog # tpau-rosakt150 lot # 6500228482.H3: 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: 3007963827-2023-00246.
Event or Problem Description
It was reported patient underwent a revision procedure two months post implantation due to instability.No more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical g4-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.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: 17754642
• Report Number: 0001822565-2023-02533
• Device Sequence Number: 17956194
• Product Code: MBH
• UDI-Device Identifier: 00889024230828
• UDI-Public: (01)00889024230828(17)321108(10)65658914
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/07/2023

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 Model Number: N/A
• Device Catalogue Number: 42502806802
• Device Lot Number: 65658914
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male