MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOS 18X150MM SPL TPR DIST; PROSTHESIS, HIP

Model Number N/A

Device Problem Collapse (1099)

Patient Problem No Code Available (3191)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Date of event - unknown; device code - unknown; expiration date - unknown; date implanted - unknown; date explanted - unknown; initial reporter; pma/510(k) number; manufacture date ¿ unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure is (or may be) needed.Should additional information be received regarding a revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.

Event Description

It was reported that the patient underwent a total hip arthroplasty on an unknown date due to unknown reasons.Patient was scheduled for a revision due to stem subsidence.The revision was cancelled due to the patient having a bad rash.No revision has been scheduled at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient underwent a total hip arthroplasty on an unknown date due to unknown reasons.Patient was scheduled for a revision due to stem subsidence.The revision was cancelled due to the patient having a bad rash.Subsequently, the patient was revised on (b)(6) 2015 due to stem subsidence.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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 can occur due to loss of fixation, trauma, malalignment, malposition, bone resorption, or excessive unusual and/or awkward movement and/or activity.¿ number 15 states, "postoperative bone fracture and pain.".

Event Description

It was reported that the patient underwent a total hip arthroplasty on (b)(6) 2015 due to unknown reasons.Patient was scheduled for a revision due to stem subsidence.The revision was cancelled due to the patient having a bad rash.Subsequently, the patient was revised on (b)(6) 2015 due to stem subsidence.

• Brand Name: ARCOS 18X150MM SPL TPR DIST
• 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: 5090576
• MDR Text Key: 26271041
• Report Number: 0001825034-2015-04018
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK090757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 11-300818
• Device Lot Number: 970050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2014
• 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