MAUDE Adverse Event Report: ARTHROSURFACE, INC. CONTOURED ARTICULAR PROSTHETIC (CAP) FEMORAL HEAD RESURFACING SYSTEM; PROSTHESIS, HIP, HEMI-, RESURFACING, METALLIC

Catalog Number H359-3065

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

The part was received by arthrosurface on 04/26/2016.The cause for the device failure is not yet concluded.The investigation is still ongoing.A supplemental mdr will be filed with the evaluation summary once the investigation is complete.

Event Description

It was reported that a 6.5 mm surface reamer was broken during a hip surgery.Then, the surgeon used a 6.0 mm reamer which broke too.The case was completed using a 7.0 mm reamer.Since the case involved two broken reamers, two separate mdrs are being filed.This mdr is specifically being filed for the 6.5 mm surface reamer.

Manufacturer Narrative

Evaluation summary: the dhr of the reamer in question (6.5mm) has been reviewed.All parts were manufactured to specifications and there were no rejected or scrapped parts from the component lot.The other reamers from the instrument set were subjected to torque test at arthrosurface engineering lab.The results revealed that all tested reamers comply to the dimensional and functional specifications.The test data will be maintained in the complaint file as a part of the arthrosurface quality system.The exact cause for malfunctioning of the device is unknown at this time.It is also important to note that this is the first incident where reamers of arthrosurface femoral head resurfacing system were reported broken since the launch of the product.The surgeon was able to finish the case using a 7.0mm reamer.There are no injuries or other serious events to the user or patient.The complaint is considered closed.

• Brand Name: CONTOURED ARTICULAR PROSTHETIC (CAP) FEMORAL HEAD RESURFACING SYSTEM
• Type of Device: PROSTHESIS, HIP, HEMI-, RESURFACING, METALLIC
• 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: 5619548
• MDR Text Key: 44223020
• Report Number: 3004154314-2016-00010
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K021549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: H359-3065
• Device Lot Number: 75DF1429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other