MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENTED FEMORAL COMPONENT; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: ng rot.Hinge knee tib plt sz4 catalog # 00-5880-004-00 lot # 63901409r, art surface 12mm fem sz e catalog # 00-5880-050-12 lot # 64834810, stem implant 12mmdx145mm catalog # 00-5988-010-12 lot # 65479568, stem implant 14mmdx145mm catalog # 00-5988-010-14 lot # 64509180, 15mm tib aug blk sz4 rlat/lmed catalog # 00-5448-004-28 lot # 63923034, 36 deg ele prov liner set 36mm catalog # 00-5490-035-02 lot # 64264990, 5mm distal fem aug sz e catalog # 00-5490-035-10 lot # 64575595.G2 : japan.H3: customer has indicated that the product will not be returned because 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 patient underwent a revision procedure nine months post implantation due to hinge post extension backed out and came off.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records provided.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.X-ray review indicates a left knee arthroplasty is present with overall anatomic alignment.The hinge post is displaced and separated from the implant with implant displacement anteroinferiorly.Radiolucency is noted along the distal aspect of the femoral implant without evidence of implant loosening.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: CEMENTED 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: 17490381
• Report Number: 0001822565-2023-02103
• Device Sequence Number: 7376848
• Product Code: KRO
• UDI-Device Identifier: 00889024199149
• UDI-Public: (01)00889024199149(17)251025(10)64731714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/12/2023

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: 10/25/2025
• Device Model Number: N/A
• Device Catalogue Number: 00588001501
• Device Lot Number: 64731714
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown