MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 DUAL MOBILITY LINER 44MM F; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please see reports: 0001825034 - 2017 - 06322, 0001825034 - 2017 - 06566, 0001825034 - 2017 - 06567.Concomitant product(s):- p/n 010000850 g7 neutral e1 liner 32mm l/n 6029297.P/n 010000928 g7 hi-wall e1 liner 32mm f, l/n 3841590.P/n 110010246 g7 osseoti 4 hole shell 56mm f 6mm f, l/n r3667101b.P/n 110024464 g7 dual mobility liner 44mm f, l/n 636070.The device has not been returned for evaluation at the time of this reporting.Follow up attempts are being done for the device(s) and/or additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the surgeon had trouble seating three liners into an acetabular cup.The acetabular cup component was switched and the liner was able to be seated.A surgical delay of 31-60 minutes was reported.No further information is available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Meaningful dimensional evaluation of the returned device was not possible as the device was impacted and therefore its specifications deformed.Upon inspection the liner shows wear on the inside radius, also there is damage along the diameter of the opening in the form of scuffs and scratches.Review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event.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 DUAL MOBILITY LINER 44MM F
• 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: 6812541
• MDR Text Key: 83295562
• Report Number: 0001825034-2017-06567
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• 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: 110024464
• Device Lot Number: 636070
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• 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): Hospitalization; Required Intervention