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

Catalog Number	11-301300
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Infection (1930); Malunion of Bone (4529)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent hip revision surgery approximately 2.5 years post implantation due to infection, periprosthetic fracture, malunion and loosening.No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues mmi: impressions: moderate-sized periprosthetic zone of lucency in the right femoral component located at the trochanteric and subtrochanteric region suggests loosening and/or infection.Device history record (dhr) was reviewed and no discrepancies were found.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.Concomitant medical products: catalog#: 11-300812 arcos 12x150mm spl tpr dist lot#: 303240.(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02539.

• Brand Name: ARCOS CON SZ A STD 50MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13178780
• Report Number: 0001825034-2022-00017
• Device Sequence Number: 4665512
• Product Code: MAY
• UDI-Device Identifier: 00880304474611
• UDI-Public: (01)00880304474611(17)280710(10)981060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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 Catalogue Number: 11-301300
• Device Lot Number: 981060
• 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: 12/28/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 55 KG