MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Event date - 2016.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments, it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.".

Event Description

It was reported that during a total hip arthroplasty, the inserter fractured during impaction.

Manufacturer Narrative

This follow up report is being filed to relay additional information.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: therapy date; unknown date in 2016, unknown acetabular cup catalog#: ni, lot#: ni.Complaint sample was evaluated and the reported event was confirmed, as the distal threads of the device were noted to be fractured.The fracture pattern of the threads is consistent to that of bending overload; however, a conclusive root cause could not be determined.The dhr was reviewed and no discrepancies were found.A summary of the investigation has been sent to the complainant.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

It was reported that during a total hip arthroplasty, the inserter fractured during impaction.The fractured piece remained in the cup; therefore, the cup was removed and replaced.No additional patient consequences have been reported.

• Brand Name: STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER
• 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: 6135003
• MDR Text Key: 61146034
• Report Number: 0001825034-2016-04888
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 636740
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2017; 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1