MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product(s): ¿ unknown stem p/n unknown l/n unknown; unknown cup p/n unknown l/n; unknown head p/n unknown l/n unknown; unknown liner p/n unknown l/n unknown.A revision has not occurred at this time, the device remains implanted.Multiple mdr reports were filed for this event.Please see reports: 0001825034 - 2017 - 06009, 0001825034 - 2017 - 06010, 0001825034 - 2017 - 06011, 0001825034 - 2017 - 06012.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Still implanted.

Event Description

It was reported the patient is scheduled for a revision for unknown reasons approximately 26 years post-implantation.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Third party reviewed the x-ray and noted "abnormal relation of the femoral head to acetabular cup".However, the reason lead to that is unknown, and the evaluation was limited by lack of a second orthogonal view.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Relevant medical history and adherence to rehabilitation protocol are unknown.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN FEMORAL HEAD
• 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: 6783216
• MDR Text Key: 82401500
• Report Number: 0001825034-2017-06011
• Device Sequence Number: 1
• Product Code: KXA
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• 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: 08/16/2017
• 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): Required Intervention