MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM ACETABULAR SHELL Ø52; ACETABULAR CEMENTLESS SHELL

Catalog Number 01.26.52MB

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 december 2015: lot 092014: (b)(4) items manufactured and released on 2o october 2009.Expiration date: 2014-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 21 december 2015 the r&d project manager analysed the available images: on the cup, the ha coating is not present anymore.Bone can be seen, mainly on the equatorial macrostructures.Observing the image of the explanted polyethilene liner, scratches can be seen on the border, caused probably by the revision surgery.Observing the image of the explanted ceramic head, scratches can be seen on it, caused probably by the revision surgery.It is not possible from the inspection of the images determine the root cause of the event.

Event Description

The patient was experiencing hip pain.The surgeon found that the cup was loose.He removed the medacta cup and liner.The surgery was completed successfully without medacta products.The explants will not be returned - images will be attached.X-rays are available.

Manufacturer Narrative

The medical affairs performed a clinical evaluation and commented as follows: cup loosening 6 years after primary implantation.Only one radiograph is available, date unknown, most probably taken before revision operation.From said radiograph, a loose cup is clearly visible, although it is conceivable that pain can also originate from a loose stem, possibly undersized.No case history is given and therefore no reconstruction of the evolution of the problem is possible.The root cause cannot be determined.The cup was not implanted in an obviously wrong position.The acetabular roof, albeit very thin, was preserved.Cup loosening is a known possible medium term complication of tha; root cause is often difficult to determine.On 01 march 2016 it was prepared a final report with the information already submitted in the initial report and here above.On 03 march 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP DM ACETABULAR SHELL Ø52
• Type of Device: ACETABULAR CEMENTLESS SHELL
• 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: 5318799
• MDR Text Key: 34131920
• Report Number: 3005180920-2015-00354
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 092014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2009
• 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