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

Catalog Number P085-0017-W/ P202-3020-W

Device Problem Unstable (1667)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/13/2015

Event Type  Injury  

Manufacturer Narrative

During patient's latest visit to the treating surgeon, it was found that there was a thick layer of scar tissue in patient's knee impeding the hemicap components from articulation.Since scar tissue is now removed, the patient is having good range of motion and is feeling comfortable with the implant.No other issues were reported regarding the functionality of the implant.Following are the details of components implanted in the patient: part # p085-0017-w, lot # 75hb1618, mfg date: 2012-08, exp date: 2017-08; part # p202-3020-w, lot # 75lb1807, mfg date: 2012-12, exp date: 2019-12.The complaint is considered closed at this time.Should there be any issues or updates, a supplemental mdr will be filed accordingly.

Event Description

Patient contacted arthrosurface to report chronic pain in the knee joint implanted with pf hemicap in (b)(6) 2015.The patient is uncomfortable with the implant and feels that the knee is popping out of the place.

• Brand Name: HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): ARTHROSURFACE, INC.; 28 forge parkway; franklin MA 02038
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, MA 02038 ; 5085203003
• MDR Report Key: 5285542
• MDR Text Key: 33249176
• Report Number: 3004154314-2015-00008
• 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: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: P085-0017-W/ P202-3020-W
• Device Lot Number: 75HB1618/ 75LB1807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2015
• 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