MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has been retained by the patient and will not be returned to zimmer biomet for investigation; however, an investigation has been initiated.Upon completion of the investigation, a follow-up mdr will be submitted.The screw involved in this event cannot be determined.It could be: catalog # - 010000998, lot # - 3624605, expiration - ni, pma # - k121874, manufacture date - ni.Or it could be: catalog # - 010000999, lot # - 3604098, expiration - ni, pma # - k121874, manufacture date - ni.Concomitant medical products- g7 acetabular shell p/n 010000662 l/n 3626596; g7 screw p/n 010000998 l/n 3624605; g7 screw p/n 010000999 l/n 3604098; femoral stem p/n 00771100600 l/n 61963053; biolox femoral head p/n 00877403201 l/n 2811973.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2017-03505, 0001825034-2017-03506.

Event Description

It was reported that the patient underwent a revision procedure three months post-implantation due to range of motion complications, squeaking during ambulation and disassociation of the liner from the acetabular shell.The liner reportedly migrated around the femoral head, resulting in the femoral head articulating with the acetabular metal shell.The surgeon indicated that one of the acetabular screws may not have been fully inserted, which would interfere with full seating of the liner.During the procedure, the acetabular screws, liner, apical hole plug and ceramic head were removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following was updated for catalog # 010000999, lot # 3604098.(b)(4).Manufacture date - aug 25, 2015.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.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 SCREW
• 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: 6607596
• MDR Text Key: 76511673
• Report Number: 0001825034-2017-03545
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• 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: SEE H10
• Device Lot Number: SEE H10
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention