MAUDE Adverse Event Report: ARTHREX INC. PLATE,TIBIAL A/P SLOPED OSTEO; PLATE, FIXATION, BONE

Catalog Number AR-13200ST-12.5

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A most likely cause(s) of this type of event include non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.

Event Description

It was originally reported that there was a breakdown of material.Follow-up investigation: progressive pain and deformity tibial osteotomy.On (b)(6) 2017 tibia osteotomy and arthrex locked plate synthesis 4 holes.45 days of crutches starting partial load after three weeks.On (b)(6) 2017 radiological evidence of partial consolidation.Beginning of (b)(6) 2017, satisfactory evolution and suddenly felt a crack and pain in the left knee without resting on lower left limb.After this episode patient began to feel pain instability and noticed that patient again had the deformity in varus.Performed simple radiographic examination and tomography.Follow-up investigation:the original surgery was performed on (b)(6) 2017; the rupture occurred 45 days post op.Date the implant was removed (b)(6) 2017.Patient: (b)(6) male.

Event Description

It was originally reported that there was a breakdown of material.No further details.Follow-up investigation: the patient underwent a tibial osteotomy surgery on the left knee on (b)(6) 2017 for varus deformity where an arthrex tibial a/p sloped osteotomy plate, ar-13200st-12.5 was implanted.The surgeon ordered 45 days of crutches starting partial load after three weeks for recovery.On (b)(6) 2017, patient was seen by his doctor and a simple radiographic examination and tomography was performed.The x-ray showed a partial consolidation of the knee.In (b)(6) of 2017, the patient had satisfactory recovery when he suddenly felt a crack and pain in the left knee without bearing any weight on the lower left limb.After this, the patient began to feel pain and instability in the left knee and realized that he again, had varus deformity.Follow-up investigation: a revision surgery was performed on(b)(6) 2017 to remove the ar-3200st-12.5.Patient: 55 year old male.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission to correct the device lot number and to update the event.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A most likely cause(s) of this type of event include non-compliance to the post-op protocol or post-op trauma to the surgical site.Per device directions for use, until bone healing is complete, fixation given with this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.

• Brand Name: PLATE,TIBIAL A/P SLOPED OSTEO
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7540111
• MDR Text Key: 109115970
• Report Number: 1220246-2018-00192
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867009660
• UDI-Public: 00888867009660
• Combination Product (y/n): N
• PMA/PMN Number: K032187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

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 Expiration Date: 03/01/2021
• Device Catalogue Number: AR-13200ST-12.5
• Device Lot Number: 10035463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR