MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ARCOS PROXIMAL BODY; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was retained by the hospital.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 was revised due to a proximal body fracture on a two-piece stem.The proximal body broke at the junction of the distal stem and proximal body.It was reported that no further information is available.

Event Description

No further information is available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: h6: proposed component code: mechanical (g04) - stem.Visual examination of the provided pictures identified the explanted proximal body is broken by the distal attachment point.Device is covered in bio-debris and no additional damage can be seen.Complaint confirmed based on the provided image and x-ray.Part and lot identification are necessary for review of device history records, neither were provided.Radiographs were provided.Review of the available records identified the following: fracture of the proximal femoral stem.Question healed fracture of the proximal femoral diaphysis.Multiple cerclage wires are present.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: UNK ARCOS PROXIMAL BODY
• Type of Device: 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: 19207890
• MDR Text Key: 341354706
• Report Number: 0001825034-2024-01096
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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,Followup
• Report Date: 05/02/2024

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: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK ARCOS STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male