MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR LINER HIGH WALL; PROSTHESIS HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Udi - ((b)(4).Delay in surgery.This report is number 2 of 2 mdrs filed for the same patient ((reference 0001825034-2017-00140 & 00184).

Event Description

It was reported that the liner would not seat in the cup.Surgery was delayed by 50 mins, was completed with a different product.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: g7 acetabular liner high wall, item # 010000812, lot # 3467552; g7 pps ltd acetabular shl 58g, item # 010000666, lot # 3863669.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-00140-1 and 0001825034-2017-00185.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.

Event Description

During a procedure, the acetabular liner would not seat in the cup.Another liner was attempted and would also not seat.The acetabular cup was removed and replaced and a new liner seated correctly.This caused delay of 50 minutes.

• Brand Name: G7 ACETABULAR LINER HIGH WALL
• 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: 6266085
• MDR Text Key: 65363762
• Report Number: 0001825034-2017-00184
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 010000929
• Device Lot Number: 3652581
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 64