MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY/TYPE I TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Concomitant medical products: arcos ha modular revision system straight tapered splined distal stem p/n 22-300814 l/n 296080.Modular head cocr p/n 164440 l/n 00j3315968.Acetabular shell regenerex porous titanium construct p/n pt-124858 l/n 642120.Advantage liner p/n p0860044 l/n 0000900990.(b)(6).This product is not cleared for distribution in the u.S.However, this report is being submitted as a similar device is cleared for distribution under 510k number k090757.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034-2017-03474, 0001825034-2017-03477, 0001825034-2017-03478, 0001825034-2017-03479.

Event Description

It was reported that patient underwent irrigation, debridement and antibiotic treatment one month post-implantation due to wound dehiscence.No products were reported to have been revised.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the event and should not have been reported.The initial report should be voided as it was submitted in error.This event has been reported in 3006946279-2017-00143.

• Brand Name: ARCOS HA MODULAR REVISION SYSTEM CONE PROXIMAL BODY/TYPE I TAPER
• 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: 6601121
• MDR Text Key: 76284899
• Report Number: 0001825034-2017-03474
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PN/A
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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: 22-301301
• Device Lot Number: 725630
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2015
• 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: 84 YR
• Patient Weight: 48