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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for instigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant product(s): g7 monoblock shell inserter, p/n 110003450, l/n unknown.Report source: (b)(6).Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2017-03491, 0001825034-2017-03492.

Event Description

It was reported that during the procedure, the inserter would not disengage from the acetabular shell.There was no patient injury or delay in the procedure as a result of the event.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed inserter and shell were stuck together.Visual inspection of the shell showed the inserter did not appear to be completely seated into the shell prior to impaction.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: G7 ACETABULAR SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6606961
• MDR Text Key: 76498708
• Report Number: 0001825034-2017-03491
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• 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: 010000665
• Device Lot Number: 3924836
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention