MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BROACH SIZE 5; PROSTHESIS, HIP

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 574101030 lot number: 3037909 brand name: avenir cmpl ha std nc size 3.Catalog number: 574101020 lot number: 3032773 brand name: avenir cmpl ha std nc size 2.Unknown broach size 2.Unknown broach size 3.Unknown broach size 4.Unknown broach size 6.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00514, 0001822565-2021-00675, 0001822565-2021-01880.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.Device not returned for evaluation.

Event Description

It was reported during an initial hip arthroplasty, that the surgeon broached with a size 2 broach.However, when he implanted the size 2 stem implant, it sank further into the bone canal than the broach.The surgeon broached then with a size 3 broach to further prep the canal.The size 3 stem implant, was implanted into the bone canal and also sank further into the canal than the broach.There was no apparent bone fractures as confirmed by radiographs.The size 3 implant was removed and the surgeon continued to further broach until it was determined that a size 6 broach was the largest size the patient¿s anatomy could accommodate.Another radiograph was taken and this time there was clearly a bone fracture in the lateral femur at the level of the distal end of the broach.The surgeon applied cerclage cables and bypassed the fracture using an acros modular revision stem.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN BROACH SIZE 5
• 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: 12181384
• MDR Text Key: 262001903
• Report Number: 0001822565-2021-01879
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR