MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A HI 50MM; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure that while unscrewing, the taper tool disengaged itself from cone.The tool ate the threading of the cone, and it was now impossible to screw back the taper tool in the cone.Surgeon inserted the cone and verified if the femoral stem was well fixated(¿it was) and decided to leave cone that was still attached to distal stem and put the lock screw back in.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products:: 31-301856 arcos taper disasmbly 50mm lot number: zb160202 report source: foreign: canada multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00827 the device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted.Device remains implanted.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.B4 b5 g3 g6 h2 h10.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: ARCOS CON SZ A HI 50MM
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16755673
• Report Number: 0001825034-2023-00828
• Device Sequence Number: 20976625
• Product Code: KWA
• UDI-Device Identifier: 00880304473799
• UDI-Public: (01)00880304473799(17)300109(10)841860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301310
• Device Lot Number: 841860
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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: Unknown
• 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
• Patient Age: 73 YR
• Patient Sex: Female