MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 70MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02508, 0001825034 - 2023 - 02509, 0001825034 - 2023 - 02510.G2: foreign: canada.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 the patient underwent a hip procedure.Subsequently, the patient underwent a third revision approximately 14 years later for unknown reasons.Attempts have mbeen ade and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint as reason for revision is unknown.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: subsequent orif/revision procedure.Revision of product due to unknown reasons.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 information at the time of this report.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: a4; a6; b7; g3; h2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: b5; d1; d2; d4; d6; g3; g4; h2.
Event or Problem Description
It was reported the patient underwent a hip procedure.Subsequently, the patient underwent a third revision approximately 14 years later due to instability and chronic periprosthetic fracture.During the revision, the surgeon noted that the cerclage wires had all essentially failed with several from the initial fixation found broken.The plate and all cables were removed, and a trochanteric bolt was placed along with new cerclage wires for fixation.The head and liner were also exchanged without complication.The patient continued to experience nonunion following the revision.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} updated: b7; d4; g3; h2; h4.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues.Chronic periprosthetic fracture left femur.Issues with stability, fibular allograft applied to some thin bone laterally.No concerns on x-ray, no further complications were noted.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.

• Brand Name: ARCOS CON SZ A STD 70MM
• Common Device Name: PROSTHESIS, 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: 18073427
• Report Number: 0001825034-2023-02507
• Device Sequence Number: 15283299
• Product Code: KWA
• UDI-Device Identifier: 00880304474314
• UDI-Public: (01)00880304474314(17)281028(10)054830
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/15/2024
• 2 Devices were Involved in the Event: 1 2

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: 11-301321
• Device Lot Number: 054830
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 05/28/2024; 06/13/2024; 07/09/2024; 11/14/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/16/2023; 06/20/2024; 06/25/2024; 07/16/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2018
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White