MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 OSSEOTI MULTIHOLE 48MM C; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Migration (4003)

Patient Problem No Information (3190)

Event Date 09/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 010000925 g7 hi-wall e1 liner 6105267, 010000847 g7 neutral e1 liner 6483876, 010001000 g7 screw 6.5mm x 35mm 6301021, 010000996 g7 screw 6.5mm x 15mm 6204657, 010000996 g7 screw 6.5mm x 15mm 6564355.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04455, 0001825034 - 2019 - 04454.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that multiple liners would not seat into the acetabular shell.Migration of the shell was noted due to the multiple impaction attempts.Attempts have been made and no additional information is available.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Udi# (b)(4).Reported event was confirmed with product return.Visual examination of the returned liners identified dimples at the apex consistent with a punch used to extract the liners from the shell.The barbs have been deformed and flattened during attempts to seat and remove the liners from the shell.Scratches and pitting were observed on the outer radius.Two distinct indentations were present on the outer radius of the high wall liner, in the shape of the head of a bone screw and a circular indentation on the outer radius of the neutral liner.The shell was also returned; scratches were observed on the shell's inner radius and rim.No damage, deformation, or debris were observed during inspection of the locking groove.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to the presence of screws impinging on the liner.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 OSSEOTI MULTIHOLE 48MM C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9155827
• MDR Text Key: 161823050
• Report Number: 0001825034-2019-04456
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K140669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010262
• Device Lot Number: 6483321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention