MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 2; 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 unknown broach.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00514, 0001822565-2021-00675.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple reports were submitted along with this report 0001822565-2021-01879.0001822565-2021-01880.D10: unknown broach size 3.Unknown broach size 4.Unknown broach size 5.Unknown broach size 6.Reported event was unable to be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

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

• Brand Name: AVENIR CMPL HA STD NC SIZE 2
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11456733
• MDR Text Key: 241746605
• Report Number: 0001822565-2021-00513
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K182048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 574101020
• Device Lot Number: 3032773
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR