MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 HIGH WALL E1 LINER 32MM D; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Date of event - ni.This report is number 2 of 2 mdrs filed for the same event (reference 0001825034-2016-02870 / 02871).Product requested, not yet received.

Event Description

During a total hip arthroplasty the liner would not seat in the shell after several attempts at impaction.Another liner was tried with the same result.The surgeon then noticed that the patient's pelvis had fractured and removed all implants to postpone the procedure until the fracture heals.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Concomitant medical product - biomet cup catalog#: 110010243 lot#: 3754245; biomet cup catalog#: 110010263 lot#: 3767351; biomet femoral stem.The liner and shell dimensions showed acceptable to print specification.On the assembled components, the oriented/alignment of the scallops visually/manually review showed within design intended.Therefore, products likely left zimmer biomet control conforming, and a root cause cannot be determined.

Manufacturer Narrative

This follow-up report is being filed to correct information.(b)(4).

Manufacturer Narrative

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

• Brand Name: G7 HIGH WALL E1 LINER 32MM D
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5844867
• MDR Text Key: 51109437
• Report Number: 0001825034-2016-02871
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000926
• Device Lot Number: 3471595
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• 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