MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 4; PROTHESIS, HIP

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported that the during a hip arthroplasty, the femoral stem fitting failed due to the stem being too far down.No additional information was available. .

Manufacturer Narrative

(b)(4) g2: foreign: country: france customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04)- stem.The product was returned and evaluated.Medical records were not provided.A visual examination of the returned product identified scratches on the neck relief and distal stem.Bio debris was noted on the stem coating from use.No other damage was noted.The dimensions of the stem were measured, and all dimensions were found to meet product specifications.A review of the device history records identified no deviations or anomalies during manufacturing.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.There was no problem found with the returned device.The dimensions met product specifications.This reported issue could not be confirmed.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 is available at the time of this report.

• Brand Name: AVENIR CMPL HA STD NC SIZE 4
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18581918
• MDR Text Key: 333746760
• Report Number: 0001822565-2024-00219
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024508644
• UDI-Public: (01)00889024508644(17)281024(10)3172023
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K182048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 Model Number: N/A
• Device Catalogue Number: 574101040
• Device Lot Number: 3172023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2023
• 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