MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIOMET ORTHOPAEDIC SALVAGE SYSTEM BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Fibrosis (3167)

Event Date 06/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: (orthopaedic salvage system - oss).Unknown oss femoral component, cat#: unknown lot#: unknown.Unknown oss assembly components, cat#: unknown lot#: unknown.Unknown oss tibial tray, cat#: unknown lot#: unknown.Unknown oss stem, cat#: unknown lot#: unknown.Unknown oss stem, cat#: unknown lot#: unknown.Unknown oss patella, cat#: unknown lot#: unknown.Initial reporter: yasser r.Farid, rishi thakral, henry a.Finn ¿intermediate-term results of 142 single-design, rotating-hinge implants: frequent complications may not preclude salvage of severely affected knees¿ the journal of arthroplasty 30 (2015) 2173-2180.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 medwatch 3500a will be submitted.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A 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.

Event Description

It was reported in a journal article that the patient experienced symptomatic arthrofibrosis as a late complication and was revised to a smaller tibial bearing.

• Brand Name: UNKNOWN BIOMET ORTHOPAEDIC SALVAGE SYSTEM BEARING
• Type of Device: PROSTHESIS, KNEE
• 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: 6765476
• MDR Text Key: 81788994
• Report Number: 0001825034-2017-05882
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2017
• 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