MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

Catalog Number 01.26.2854M

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 an expert surgeon performed a preliminary investigation based on the x-rays and commented as follows: the head is eccentrically located so there has been obvious massive poly wear in a very short time period.On 20 may 2016 the (b)(4) performed a clinical evaluation and commented as follows: massive osteolysis in a double mobility cementless tha at 6+ years postoperative.The x-ray images are compatible with abnormal polyethylene wear, but this can only be proved at revision.The explants should undergo technical examination to look for evidence of abnormal wear.No other possible clinical cause can be detected from the available information.Batch reviews performed on 01 june 2016.Lot 092228: (b)(4) items manufactured and released on 25 september 2009.Expiration date: 2014-08-31.No anomalies found related to the problem; everything was found in accordance with the specifications valid at the time of production.To date, all items of this lot have been already sold without any similar reported event.Quadra-h cementless, ha coated stem size 5 lat, code 01.12.035, lot.083622 (k082792) (b)(4) items manufactured and released on 03 february 2009.Expiration date: 2013-12-31.No anomalies found related to the problem; everything was found in accordance with the specifications valid at the time of production.To date, all items of this lot have been already sold without any similar reported event.Versafitcup acetabular shell ø 54, code 01.26.54mb, lot.092015 (k083116) (b)(4) items manufactured and released on 29 october 2009.Expiration date: 2014-08-31.No anomalies found related to the problem; everything was found in accordance with the specifications valid at the time of production.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cocr ball head 12/14 ø 28 size xl +7, code 01.25.014, lot.090794 (k072857) (b)(4) items manufactured and released on 27 april 2009.Expiration date: 2014-03-31.No anomalies found related to the problem; everything was found in accordance with the specifications valid at the time of production.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 03 june 2016, it was communicated that at this time there is not further information about the revision surgery.Not yet explanted.

Event Description

The patient came in complaining of pain.The surgeon took x-rays which show a "massive lysis." a revision will be done however the revision surgery date is still yet to be determined.X-rays are available.

Manufacturer Narrative

Additional information received on 02 june 2016 and includes: the patient had osteolysis.The surgeon removed all medacta implants on (b)(6) 2016.The surgery was completed successfully.On 10 june 2016 the medical affairs director confirmed that, on the basis of the fluoroscopy image, there are no additional considerations to the previously reported clinical evaluation.On 27 june 2016 the r&d project manager analysed the returned implants: on the femoral head no particular signs can be seen.The head is not freely articulating in the liner.On the shell no particular signs can be noted, except on the border where some scratches were probably caused during the removal phase.On the liner some scratches on the border can be seen, probably caused by the revision surgery.The external surface of the liner is slightly yellow probably due to lipid absorption.After the visual inspection, the head was disassembled from the liner: the liner will be measured by the control quality department.We will wait the report of the cq department.To date, it is not possible from the inspection of the implants determine the root cause of the event.

Manufacturer Narrative

Quality control metrological analysis on the pe liner performed on 22.Jul.2016: the measures are in complaince with the drawing.No issue was found.

Manufacturer Narrative

An additional analysis was performed on the subject liner.It was measured by our quality control department.In order to disassemble the femoral head, the central hole of the liner was enlarged.The external surface of the liner was not considered, because too many scratches were noted on it: they were probably caused during the revision surgery and the disassembling of the two components (liner and head).For these reasons (central hole and damaged external surface) a gravimetric analysis on the retrieved polyethylene component was not possible.The external diameter of the liner conforms with the relative drawing.The internal diameter was measured with two different methods of control.With the first method the internal diameter is conforming to the specifications, more than 0.07mm below the upper tolerance of the quote; with the second method the internal diameter is about 0.06mm above the upper tolerance.The centre of the starting internal spherical surface, moved toward the pole of the specimen about 1.5mm.Moreover, the controlled shape is no more axial symmetric: the implantation parameters of both cup and lat stem may have influenced the stresses transmitted to the liner and therefore caused a decentralization of the head inside the liner.The modification of the internal surface of the liner was caused by plastic deformation and wear: in fact, when evaluating the quantitative wear of polyethylene liners by shape discrepancy, it is also necessary to consider the cold-hot phenomenon.This event takes place in the first few months of implant life and results in plastic deformation of polyethylene liners and cups without generation of wear debris.Considering 120 mg (=125mm3) per million cycles as critical threshold for the development of osteolysis, referring to the total polyethylene wear amount, we compared the shape discrepancy of the retrieved liner with the critical threshold, after about 6 and a half years of implantation.The difference in shape of the analyzed portion exceeds 20% the value fixed as critical threshold.Considering the shape of the internal surface, the diameter of the sphere that best approaches this surface (see above), and the migration of the head centre, a part of the shape difference is likely due to the plastic deformation after years of load.From the analysis of the shape were excluded the central hole and 2.5mm of the equatorial portion because highly damaged and outside the volume of interest.Moreover, a wear test according to iso 14242-1, iso 14242-2 and astm 732-00 (international & us standards for wear testing) was run in the past on the worst case of the range of double mobility liners.The measured polyethylene wear is very far from the critical threshold for the development of osteolysis.With conventional uhmwpe, the average wear rate of 35.57±2.15 mg per million cycles is more than three times inferior to the amount of 120 mg (=125mm3), defined as critical threshold.The liner before being returned to medacta endured a washing and probably a sterilization process: that may have influenced the polyethylene part.Also the disassembling of the femoral head from the liner may have influenced the final dimensional controls.Considering the above mentioned, there is no evidence of abnormal wear on the surface of the liner.The root cause of the event cannot be determined.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
• Type of Device: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5697063
• MDR Text Key: 46492683
• Report Number: 3005180920-2016-00263
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 01.26.2854M
• Device Lot Number: 092228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2009
• 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): Required Intervention