MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MODULAR HEAD COMPONENT 28MM HEAD DIAMETER MINUS 3MM NECK; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Joint Dislocation (2374)

Event Date 11/11/2016

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 that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur under possible adverse effects, number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 8 states "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-05136 / 05137).

Event Description

It was reported that the patient underwent a revision procedure approximately nine years due to dislocation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Device was not returned so no physical evaluation of product could be conducted.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.This type of event is addressed in associated package insert and risk documentation.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: MODULAR HEAD COMPONENT 28MM HEAD DIAMETER MINUS 3MM NECK
• 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: 6156698
• MDR Text Key: 61849370
• Report Number: 0001825034-2016-05136
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 163661
• Device Lot Number: 636570
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2006
• 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