MAUDE Adverse Event Report: ARTHREX INC. IMPLANT SYSTEM INTERBRACE KNEE LIG AUGMENT REPR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	AR-5511-CP
Health Effect - Clinical Codes	Inflammation (1932); Irritation (1941); Swelling (2091)
Date of Event	09/13/2016
Type of Reportable Event	Serious Injury
Additional 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.The contribution of the device to the reported event could not be determined as the device remained in the patient 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 possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported by a regional manager, that a patient is having complications from a swivelock implant.No further details were provided.Rep will call in with the rest of information.Follow up investigation: it was reported to the sales representative from the patient that she is experiencing a lot of soft tissue irritation, soreness and swelling.The irritation is around the tibial insertion.The patient states that she was healing fine until she walked extensively in high heels.A mri has been performed and confirmed that the implant is still in the bone.She has continued physical therapy and has bursitis formation.Follow up investigation: patient's symptoms started in (b)(6) 2017 after walking in high heels.
Additional Manufacturer Narrative
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 a follow-up submission to reflect additional event information.The contribution of the device to the reported event could not be determined as the device remained in the patient 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 possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported by a regional manager, that a patient is having complications from a swivelock implant.No further details were provided.Rep will call in with the rest of information.Additional information received 8/30/2017: it was reported to the sales representative from the patient that she is experiencing a lot of soft tissue irritation, soreness and swelling.The irritation is around the tibial insertion.The patient states that she was healing fine until she walked extensively in high heels.A mri has been performed and confirmed that the implant is still in the bone.She has continued physical therapy and has bursitis formation.Additional information obtained from patient: surgery took place (b)(6) 2016, not (b)(6) 2017 as originally reported by sales rep.Surgery was a grade 3 mcl rupture repair.At time of patient additional information patient stated it had been seven months since the event that led to what she feels may be a possible internal brace failure.Time is not healing the new pain and inflammation.Walking is limited, full extension is limited to brief periods only and pain with transitions from sitting to standing is reported to be debilitating.The inside of the joint itself does not hurt and at last follow up visit yielded minimal fluid during an extraction attempt despite significant selling around the knee.Patient stated the swelling is in the external tissues and the knee joint itself is stable and functions appropriately.In addition, sleeping has become increasingly difficult, as finding a position the knee does not hurt in is tricky.Patient feels the device has is not working as intended and needs removal.Exact date of surgery and additional medical records have been requested.

• Brand Name: IMPLANT SYSTEM INTERBRACE KNEE LIG AUGMENT REPR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6873250
• Report Number: 1220246-2017-00340
• Device Sequence Number: 13833793
• Product Code: MAI
• UDI-Device Identifier: 00888867109698
• UDI-Public: 00888867109698
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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
• Operator of Device: Health Professional
• Device Model Number: AR-5511-CP
• Device Catalogue Number: AR-5511-CP
• Device Lot Number: 10028597
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other