MAUDE Adverse Event Report: ARTHROSURFACE, INC. UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS (UNICAP); KNEE JOINT FEMOROTIBIAL METAL/POLYMER NONCONSTRAINED CEMENTED PROSTHESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The exact reason for the reported issues is unknown.The date of surgery, implant information or clinical history of the patient is currently unknown without which the investigation of the issues is not possible.All arthrosurface hemicap® implants contain nickel in trace quantities.It is possible that patient's sensitivity to nickel may have led to the issues reported.The implant package insert states that arthrosurface hemicap® devices are contraindicated for patients that have a known sensitivity to materials typically used in orthopedic prosthetic devices or bone cements.Published literature shows evidence of implant-related complications in patients with metal sensitivity.The patient was advised to consult her implanting physician and discuss her issues.Should arthrosurface receive additional information from the patient, the information will be reviewed and reported accordingly.

Event Description

The patient indicated in an email that she is having varying levels of pain and discomfort in her knee implanted with arthrosurface hemicap® device.She wants to know if hemicap® implants contain nickel as, a recent metal-ltt analysis resulted her in a positive sensitivity to nickel.

Manufacturer Narrative

This supplemental mdr is being filed to update the implant information previously filed in mdr # 3004154314-2018-00001.The patient currently has a unicap implant in her knee.Unicap is a part of the hemicap family.

• Brand Name: UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS (UNICAP)
• Type of Device: KNEE JOINT FEMOROTIBIAL METAL/POLYMER NONCONSTRAINED CEMENTED PROSTHESIS
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton MA 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 7212355
• MDR Text Key: 97984979
• Report Number: 3004154314-2018-00001
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other