MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 6.5MM X 25MM SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 08/09/2016

Event Type  Injury  

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.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure." product location unknown.

Event Description

During a hip arthroplasty procedure after the surgeon tightened a screw into the shell, the screw head was reported to be protruding as the surgeon implanted the screw obliquely.Subsequently, the surgeon continued to tighten until the screw went through the shell's screw hole.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

During a hip arthroplasty procedure after the surgeon tightened a screw into the shell, the screw head was reported to be protruding as the surgeon implanted the screw obliquely.Subsequently, the surgeon continued to tighten until the screw went through the shell's screw hole.The same screw and shell were removed from the patient and used to complete the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: G7 6.5MM X 25MM SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 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: 5941130
• MDR Text Key: 54397449
• Report Number: 0001825034-2016-03555
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 010000998
• Device Lot Number: 3822944
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• 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): Other; Required Intervention; Disability