MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOS 16X250MM INTERLOCKING DISTAL HA; PROSTHESIS, HIP

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 04/17/2015

Event Type  Injury  

Event Description

It was reported that patient underwent initial total hip arthroplasty on an unknown date with unknown products.Subsequently, patient was revised on (b)(6) 2015 due to unknown reasons.During the procedure, the target arm was aligning correctly before insertion, however, after insertion the drilled screw holes could not be aligned and an x-ray was required to implant the screws free-hand.The stem was inserted, removed, and then reinserted during its placement into the patient and the connection of the nail was checked to confirm it was still locked in the correct orientation on the target arm.Two sizes of trial cone bodies and the definitive implant would not lock into place over the definitive distal stem.As a result, the implant is relying on the strength of only the morse taper junction.This caused a surgical delay of approximately 60 minutes.

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 warnings, number 3 states, "tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure.".

Manufacturer Narrative

Event description - the initial hip implant was a competitor product.This medwatch is to clarify that the delay during the revision procedure to implant the biomet hip is the reason for the medwatch report.

Event Description

It was reported that patient underwent a revision hip arthroplasty procedure on (b)(6) 2015 to replace a competitor hip with a biomet hip.During the procedure, the surgeon utilized a target arm to drill holes and align screws with the femoral cone body and the distal stem; however, the screw holes could not be aligned and an x-ray was required to implant the screws free-hand.The stem was inserted, removed, and then reinserted during its placement into the patient and the connection of the nail was checked to confirm it was still locked in the correct orientation on the target arm.Two sizes of trial cone bodies and the definative implant would not lock into place over the definative distal stem.As a result, the implant is relying on the strength of only the morse taper junction.This caused a surgical delay of approximately 60 minutes.

• Brand Name: ARCOS 16X250MM INTERLOCKING DISTAL HA
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4772689
• MDR Text Key: 5947963
• Report Number: 0001825034-2015-02044
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 22-301916
• Device Lot Number: 825180
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2012
• 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