MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MODULAR LATERALIZED TAPERLOC FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Difficult to Remove (1528)

Patient Problem Hip Fracture (2349)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 1 of 2 mdrs filed for the same patient (reference 1825034-2016-05452 & 05455).

Event Description

During a right hip revision procedure, the sleeve was found to be corrosively welded to the stem.During impaction to removed the sleeve from the stem, the entire stem was removed.An x-ray revealed nondisplaced greater trochanter fracture.Cables were used to fix the fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant products: m2a-magnum taper adapter, catalog#:11-103207, lot#:156930.Device was not returned so product evaluation could be conducted.This device was used for treatment.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.Review of the operative notes indicated patient underwent an initial right tha procedure successfully with no complications.Implants gave good fit and stability through full range of motion.Operative notes revealed patient underwent a revision procedure approximately five (5) years post implantation due to metallosis and osteolysis.The head, taper, and stem were removed and replaced with competitor femoral components and an active articulation bearing.It was noted; metallosis type debris throughout the hip and sleeve cold welded to the stem.Surgeon had to use a diamond-tipped metal cutting burr to cut a wedge resection of the sleeve from stem.No delay was mentioned during this process.X-rays showed a non-displaced greater trochanter fracture that had to be repaired during the revision surgery after the stem was removed with difficulty.Cables were used to repair the fracture.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 LATERALIZED TAPERLOC FEMORAL STEM
• 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: 6216452
• MDR Text Key: 63687298
• Report Number: 0001825034-2016-05452
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 11-103207
• Device Lot Number: 156930
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2008
• 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
• Patient Age: 75 YR