MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER; PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It was reported that during inspection, threads of the inserter were noted to have been damaged.There was no patient involvement or delay in a procedure reported.

Manufacturer Narrative

This follow up report is being filed to relay corrected and additional information.Additional: investigation results concluded that after review of device history records found these units were released to distributor with no deviations or abnormalities.Visual inspection of the product confirms the complaint.The fracture pattern of the threads is consistent to that of bending overload.Inspection of the device shows evidence of heavy use.Based on the surgical technique, page 20, "note: levering on the inserter handle or impacting the handle on a location other than the strike plate to reposition the shell may damage the threads." if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during inspection, the threads of the inserter were noted to have been damaged.There was no patient injury or delay in a procedure reported as a result of the event.Attempts have been made, but no additional information is available.

• Brand Name: G7 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: 6151991
• MDR Text Key: 61710174
• Report Number: 0001825034-2016-05051
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110003450
• Device Lot Number: 220810
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1