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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Viral Infection (2248); Fungal Infection (2419)

Event Date 07/01/2009

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant medical product: unknown oss femoral component, cat#: unknown lot#: unknown; unknown oss bearings, cat#: unknown lot#: unknown; unknown oss assembly components, cat#: unknown lot#: unknown; unknown oss stem, cat#: unknown lot#: unknown.Initial reporter: nathan f gilbert, md., alan w.Yasko, md., scott d.Oates, md., valerae o.Lewis, md., christopher p.Cannon, md., and patrick p.Lin, md.¿allograft ¿ prosthetic composite reconstruction of the proximal part of the tibia¿ analysis of early results the journal of bone and joint surgery¿ 2009,91:1646-56.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05799, 0001825034-2017-05800, 0001825034-2017-05802, 0001825034-2017-05803.

Event Description

It was reported in a journal article that one (1) patient diagnosed with an osteogenic sarcoma with a medial gastrocnemius rotational flap experienced an acute deep wound infection, polymicrobial in nature which occurred approximately eight weeks post-surgery.Treatment consisted of early aggressive surgical debridement and intravenous antibiotics followed by long term oral antibiotics.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product: unknown oss femoral component, cat#: unknown lot#: unknown.Unknown oss bearings, cat#: unknown lot#: unknown.Unknown oss tibial tray, cat#: unknown lot#: unknown.Unknown oss assembly components, cat#: unknown lot#: unknown.Unknown oss stem, cat#: unknown lot#: unknown.Unknown patella, cat#: unknown lot#: unknown.The device will not be returned for analysis, as its location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05799, 0001825034-2017-05800, 0001825034-2017-05801, 0001825034-2017-05802, 0001825034-2017-06293, 0001825034-2017-06294.The information contained within this report does not alter previous conclusions.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.

• Brand Name: UNKNOWN BIOMET ORTHOPAEDIC SALVAGE SYSTEM TIBIAL TRAY
• 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: 6765736
• MDR Text Key: 81792107
• Report Number: 0001825034-2017-05801
• 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,Followup
• Report Date: 08/14/2017

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 Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 08/03/2017
• Supplement Dates Manufacturer Received: 08/11/2017
• Supplement Dates FDA Received: 08/14/2017
• 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