MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 OSSEOTI 3 HOLE SHELL; HIP PROSTHESIS

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion to the cause of the event.The following could not be completed with the limited information provided.Date of event - ni, device product code - ni, expiration date - ni, unique identifier (udi) # - ni, date implanted - ni, date explanted - ni, manufacture date ¿ ni.

Event Description

During an initial hip procedure, the liner would not seat in the shell.A delay of less than 30 minutes was reported.

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).

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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 OSSEOTI 3 HOLE SHELL
• Type of Device: HIP PROSTHESIS
• 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: 6338585
• MDR Text Key: 68012833
• Report Number: 0001825034-2017-00716
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK140669
• 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
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110010243
• Device Lot Number: 3799760
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided; 12/15/2017
• Supplement Dates FDA Received: 03/10/2017; 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• 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