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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Separation Failure (2547); Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); No Information (3190)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: biomet echo femoral catalog#: 12-150313 lot#: 907150.(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

A patient who underwent a total hip arthroplasty on an unknown date has been indicated for revision due to unknown reasons.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.

Manufacturer Narrative

This follow up report is being filed to relay corrected information.

Event Description

It was reported that during a primary hip the cup and liner was popped out during trialing of the head.The liner removal instrument was not available so surgeon tried to remove with osteotome but felt it was too difficult on the back table with no leverage so it was opted to open new implants and put a screw into the new cup.

Manufacturer Narrative

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

Event Description

It was reported that during an initial hip arthroplasty procedure, the acetabular shell migrated out of position when trialing the femoral head.The cup was removed resulting in a delay of unknown length.A new acetabular cup and liner were used to complete the procedure.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Reported event was unable to be confirmed as part number / lot number of device involved in the incident was unknown.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: UNKNOWN G7 ACETABULAR CUP
• 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: 6415441
• MDR Text Key: 70301311
• Report Number: 0001825034-2017-01602
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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