MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS; KNEE JOINT PATELLO-FEMORAL RESURFACING PROSTHESIS

Model Number PX02-0218 / PX02-0705-W

Device Problem Metal Shedding Debris (1804)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The exact reason for the metallosis is not known.According to arthrosurface engineering, the inner surface of the pfxl articular implant taper showed no signs of metal wear.However, wear/damage was noticed on the outer surface of the ti fixation components.From radiographs obtained, it cannot be confirmed, but it appears that the tapers were not seated properly, possibly from the initial implantation.As such, this may have caused rocking movement leading to the friction between both components.Review of the complaint history indicated no prior complaints for the part-lot combinations associated with the reported devices.Review of device history records (dhrs) identified no manufacturing deviations that would have caused or contributed to the reported issue.All arthrosurface hemicap implants undergo wear, corrosion and fretting tests as a part of their design and developmental stages.No occurences of material disintegration or decomposition have been reported in any arthrosurface hemicap implant history.Based on the information available, no further conclusions can be drawn.The complaint is considered closed at this time.Manufacturing and expiry dates of the implants under question are specified below part # px02-0705-w, lot # 75hb3020, mfg.Date: 08-2012, exp.Date: 08-2019.Part # px11-0218-w, lot # 75hb2020, mfg.Date: 08-2012, exp.Date: 08-2017.

Event Description

Patient has arthrosurface pfxl hemicap implanted ((b)(6) 2012) in conjunction with stryker's ukr implant.The implantation date of stryker components is not known.The patient presented with pain in his left knee to the clinic after 2 weeks of arthroscopy and complains that he doesn't get pain relief as expected.Surgical findings revealed advanced arthritic disease in the lateral compartment.In his report dated (b)(6) 2016, the surgeon suspects that a titanium reaction leading to metallosis is caused at the trunnion where the two arthrosurface pfxl components join.The surgeon states that there were no signs of surface wear or damage or loosening of either of the implants.However, the implant was loose at the time of revision ((b)(6) 2016).

• Brand Name: HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
• Type of Device: KNEE JOINT PATELLO-FEMORAL RESURFACING 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: 6078003
• MDR Text Key: 59123543
• Report Number: 3004154314-2016-00014
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PX02-0218 / PX02-0705-W
• Device Lot Number: 75HB2020 / 75HB3020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 44 YR