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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 650-1057 lot# 142150 cer bioloxd option hd36mm.Cat# 650-1066 lot# 571430 cer opt type 1 tpr sleve 0mm.Cat# unk lot# unk 5 cerclage wires.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had a hip revision due to a right broken stem implant.There were no surgical complications.Though requested, no additional information was available.

• Brand Name: ARCOS CON SZ A STD 70MM
• Type of Device: PROTHESIS, 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: 19010939
• MDR Text Key: 338998841
• Report Number: 0001825034-2024-00772
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304474314
• UDI-Public: (01)00880304474314(17)260304(10)963440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-301321
• Device Lot Number: 963440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male