MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS; KNEE JOINT PATELLOFEMORAL POLYMER/METAL SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Device Problems Failure To Adhere Or Bond (1031); Improper or Incorrect Procedure or Method (2017)

Patient Problems Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

On 02/01/2016, after discussions with the regional manager, arthrosurface ceo attempted to contact the patient and left a voicemail.The call was never returned by the patient.Arthrosurface deduced below conclusions from patient's text.1.The uni knee replacement was manufactured by (b)(4).It is not an arthrosurface device.2.The patello-femoral implant was manufactured by arthrosurface which is made of cocr.It is not titanium as patient indicated.It is used in conjunction with a titanium fixation component.It is indicated for use with uhmwpe patella component, which was not implanted by the surgeon.3.The other surgical complaints could not be confirmed.The information is limited and it is unclear to what degree arthrosurface components contributed to the pain.As per arthrosurface regional manager, the treating surgeon attempted to contact the patient on 01/27/2016 and had not spoken as of 02/22/2016.Efforts are ongoing to contact patient and if further information is available, it will be reported through a supplemental mdr.

Event Description

On (b)(6) 2016 a patient reached out to the treating surgeon via a text message to report the indications from a second opinion where the physician correlated pain to the mri images.Following is the verbatim of the patient's text.1.Damaged / torn quadriceps leading to generation of chronic pain.Tendons needing to be surgically repaired.2.Constant gnawing pain where the calf muscles and hamstrings join.Mri shows an object that was left in the leg from the surgery.3.Aching pain from the loosening of tibial implant.4.Exposed metal implant is causing chronic pain and swelling in the patella.Patient did not want the metal implant without cemented poly patella as he is aware that titanium would be problematic to the soft tissue.5.As a result of surgical errors, he is in pain and the surgery has crippled him.The patient previously received smith & nephew uni device with arthrosurface patello-femoral implant on the femoral side only.Surgeon did not use the patella implant as indicated.On same day, the surgeon and the patient forwarded the text to arthrosurface.

• Brand Name: HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
• Type of Device: KNEE JOINT PATELLOFEMORAL POLYMER/METAL SEMI-CONSTRAINED 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: 5466698
• MDR Text Key: 39255760
• Report Number: 3004154314-2016-00002
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• PMA/PMN Number: K060127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• 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
• Date Manufacturer Received: 01/26/2016
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other