MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS 18X190MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 11/26/2018

Event Type  Injury  

Event Description

It was reported that during a revision procedure, the surgeon performed final implant for function, and while rotating the hip, the right lower extremity did not rotate with the hip.Surgeon found a distal femoral transverse fracture had occurred.The distal fracture was reduced with competitor plating system.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 00-6250-065-25 lot 62869681 bone screw 6.5x25 selftap.Ref 00-8757-052-01 lot 62831028 continuum cluster-hole shell, 52.Ref 98-0001-005-80 lot por st/tm cup/lg vit e.Ref# unk lot# unk synthes periarticular distal femoral locking plate.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

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.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues during impaction, which appeared to have a continuation of the trochanteric fracture extending into the posterior cortex and this appeared to extend distally towards the shaft of the femur.A review of the device history records identified no related deviations or anomalies during manufacturing.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 Description

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

• Brand Name: ARCOS 18X190MM SPL TPR DIST
• Type of Device: 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: 13191463
• MDR Text Key: 283402893
• Report Number: 0001825034-2022-00065
• Device Sequence Number: 1
• Product Code: MAY
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11-300918
• Device Lot Number: 214300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White