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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Hip Fracture (2349)

Event Date 07/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown which screw was fractured and left in situ.The other screw information is 010000999, g7 screw 6.5mm x 30mm, lot 2982204.Concomitant medical products: 010000663, g7 pps ltd acet shell 52e, lot 3002716, 010000849, g7 neutral e1 liner 32mm e, lot 3081919, 163667, 32mm mod head cocr -6mm neck, lot 319760, unknown stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2014-07734.

Event Description

It was reported patient¿s hip was revised approximately 8 months post implantation due to pain, discomfort, with superolateral subluxation attributed to periprosthetic acetabular fracture and migration of acetabular component.Lack of boney ingrowth was noted.A fractured screw was unable to be retrieved and was left in patient.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi: (b)(4).Reported event was confirmed by review of medical records.Op notes were reviewed and verified that the patient had underwent a revision due to migration, acetabular failure of ingrowth, and periprosthetic acetabular fracture.There was a note about a broken screw being found while removing the liner and acetabular component.The broken screw fragment could not be removed and the head of the screw was burred down to allow for reaming.The device history records for item # 010000998, lot # 29822003 were reviewed for deviations and/or anomalies with no deviations and/or anomalies that would have attributed to the event.The device history records for item # 010000999, lot # 2982204 were reviewed for deviations and/or anomalies with no deviations and/or anomalies that would have attributed to the event.A definitive root cause cannot be determined with the information 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.

Event Description

No further event information available at the time of this report.

• Brand Name: G7 SCREW 6.5MM X 25MM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8300922
• MDR Text Key: 134861123
• Report Number: 0001825034-2019-00424
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 010000998
• Device Lot Number: 2982203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 93