MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 3; PROSTHESIS, HIP

Catalog Number 574101030

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Item # 010000661/ g7 pps ltd acet shell/lot # 7136829, item# 30103203/ g7 vit e neutral ln/ lot # 65059603.Item # 00-8775-032-01/ biolox delta fem head/lot # 3084023, item# 574101030/ avenir cmpl ha std nc / lot# 3070237.

Event Description

It was reported that during an initial hip surgery the surgeon broached to a size 3 avenir then proceeded with a trial reduction, the size 3 std avenir implant was then impacted and sat 10mm proud from the resection level.At this point, the surgeon decided to remove the implant to check tolerances for return.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6 h6: component code mechanical - g04 code (stem) visual review of the device identified taper shows deformation damage at the edge.Neck shows nicks, gouges, and scratches.Porous coating showing damage at the proximal end near the extraction hole and at the distal end.No other damage was noted.The device was found to be conforming to specifications during manufacturing.Review of the device history records identified no (related) deviations or anomalies during manufacturing.A definitive root cause could not 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: AVENIR CMPL HA STD NC SIZE 3
• 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: 13508799
• MDR Text Key: 285696628
• Report Number: 0001822565-2022-00392
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 00889024508637
• UDI-Public: (01)00889024508637(17)260625(10)3069370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182048
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 574101030
• Device Lot Number: 3069370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• 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 Sex: Female