MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE KNEE LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01088 and 0001822565-2024-01089.D10 medical devices: rotating hinge knee 23mm height size e articular surface catalog#: 00588005023 lot#: 64834849.Unknown rotating hinge knee tibial tray catalog#: ni lot#: ni.G2 foreign source: canada.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.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 the patient underwent a left knee knee revision approximately five years post-implantation due to implant fracture.No additional patient consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
D10 medical devices: rotating hinge knee 23mm height size e articular surface catalog#: 00588005023 lot#: 64834849 tibial central cone size x-small catalog#: 42545000510 lot#: 64978419 15mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801015 lot#: 65142992 femoral augment block distal only precoat size e 15 mm augment with screw catalog#: 00599003523 lot#: 64103994 size 4 precoat cemented tibial component catalog#: 00588000400 lot#: 65245266 femoral central cone size medium catalog#: 42545001012 lot#: 64597582 femoral augment block distal only precoat size e 15 mm augment with screw catalog#: 00599003523 lot#: 63138133 22mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801022 lot#: 64546954.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Updated: b4, b5, g3, g6, h2, and h11.Corrected: d6a.D6a implant date: the previously reported implant date was reported in error.The implant date is unknown.
Event or Problem Description
It was reported that patient underwent a left knee arthroplasty.Subsequently, patient was revised due to implant fracture.No additional patient consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Proposed component code: mechanical (g04) - femur.Reported event was confirmed by review of photograph.Visual examination of the provided pictures identified the hinge post of the femoral implant is bent, warped, twisted.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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.

• Brand Name: ROTATING HINGE KNEE LEFT SIZE E CEMENTED OPTION FEMORAL COMPONENT
• 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: 19020025
• Report Number: 0001822565-2024-01088
• Device Sequence Number: 3875689
• Product Code: JWH
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)251209(10)64862642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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,Followup,Followup
• Report Date (Section B): 08/05/2024

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: 12/09/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 64862642
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/01/2024; 06/18/2024; 07/25/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/25/2024; 07/12/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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; SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male