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

Catalog Number P306-0090-W

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

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

Event Type  Injury  

Manufacturer Narrative

Based on information in the medwatch report, the patient received only the patella implant of the pf system during her knee surgery in 2014.The surgeon did not use the accompanying femoral trochlear implant which makes it an off-label use.Hence, the current complications reported by the patient cannot be attributed to the device in question.The device ifu has the description of the implant and the intended uses of the pf wave hemiarthroplasty system.The device history record of the device lot in question was reviewed and no issues were noted.The patient underwent a tkr in (b)(6) 2016 during which arthrosurface patella device was removed.The complaint will be considered at this time.Any further information received will be reviewed for reportability and submitted via supplemental mdrs.

Event Description

Arthrosurface received an fda medwatch report (report # mw5095188) on 08/16/2020 filed by a customer who is currently experiencing issues with her knee.According to the medwatch report, the customer received a partial knee replacement using arthosurface pf implant in (b)(6) 2014.From day one of the surgery, the pain increased, and the knee deteriorated to the point it was debilitating.Her knee had to be drained a few times as the fluid was filling in the joint.A second surgeon performed a knee arthroscopic abrasion arthroplasty after diagnosing the patient with infrapatellar contracture syndrome (ipc).During a post-op visit, the surgeon advised patient that she would need a total knee replacement (tkr) in the next 9-12 months and that she needs to start working work on strengthening the leg in preparation for tkr.After connecting with a couple of physicians recommended by patello-femoral foundation, the patient learned that she did not have icp and that the she received only the uhmwpe patellar component of the arthrosurface pf implant but not the femoral trochlear counterpart.The patient was revised to a tkr since 2016.However, she is still experiencing pain and balance issues.

• 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
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton, ma
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, ma ; 5203003
• MDR Report Key: 10391214
• MDR Text Key: 202448399
• Report Number: 3004154314-2020-00004
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: P306-0090-W
• Device Lot Number: 75FC2412
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2013
• 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