MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TAPERLOC COMPLETE SIZE 4MM AND XR 123; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.This report is 1 of 2 mdrs filed for the same event/patient (reference 0001825034-2017-02103).

Event Description

During a procedure, the femoral stem sat proud after broaching.An alternative stem was attempted after broaching again, and it still didn't sit as expected.The surgeon felt the fit was acceptable and the procedure was completed without further incident.There was no significant delay reported as a result of the event.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was not confirmed.Visual inspection found the rasp to be in pristine condition.No damage was observed.Dimensional analysis was conducted according to the inspection criteria.The measured overall length, porous gap and porous profile measurements conform to print specifications.Device history record (dhr) was reviewed and no discrepancies were found.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.This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow up report is being submitted to report additional information.

• Brand Name: TAPERLOC COMPLETE SIZE 4MM AND XR 123
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6450759
• MDR Text Key: 71468770
• Report Number: 0001825034-2017-02112
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 51-203120
• Device Lot Number: 254707
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR