MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ARCOS REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL 16X190 STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Date 06/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 -2018 -07564; 0001825034 -2018 -07565; 0001825034 -2018 -07568; 0001825034 -2018 -07574; 0001825034 -2018 -07579.Concomitant medical products: unk part/lot-, proximal body, head, taper adaptor, 010000662 shell, lot 3423437; 010000848 liner, lot 3309813.Reported event was confirmed due to review of provided medical records and/or patient x-rays.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Not returned to manufacturer.

Event Description

It was reported the patient presented with a draining hip wound with a small, punctate area of serous fluid.Incision and drainage performed above the fascial layer where a small granuloma was noted and assumed to be the cause of the drainage.No further complications noted.

• Brand Name: BIOMET ARCOS REVISION SYSTEM STRAIGHT TAPERED SPLINED DISTAL 16X190 STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7767422
• MDR Text Key: 116557182
• Report Number: 0001825034-2018-07561
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2018

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Weight: 76