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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/18/2015

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.

Event Description

It was reported that attempts to remove the femoral head from the stem were unsuccessful, as the taper adapter was cold welded to the stem.During the attempted removal, the patient experienced a femoral bone fracture.Due to the fracture, the femoral stem was also removed and replaced during the revision procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.Revision operative reports noted that the femoral head and taper were cold-welded together.With the repeated impactions on the femoral head with the last impaction, the femur suffered a proximal femoral metaphyseal fracture through the anterior and posterior portion of the femur, then passed 2 cerclage cables, 1 at the distal extent and 1 just below the lesser trochanter.This reattached the proximal tube nicely.When reaming by hand the fracture propagated and displaced and the trochanter appeared damaged placed a real 17 x 155 conical stem, placed a trial body, reduced the hip, and obtained x-rays to confirm that this was an intimate fit on the ap.Range of motion found to be stable.Review of complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and associated risks are addressed in risk documentation.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 TAPERLOC FEMORAL
• 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: 6214188
• MDR Text Key: 63590154
• Report Number: 0001825034-2016-05387
• 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: consumer,distributor,health p
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 12-103207
• Device Lot Number: 080050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2009
• 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
• Patient Age: 63 YR