MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 50

Catalog Number 01.26.50MB

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Joint Disorder (2373)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

Additional information received on 15 march 2017 and includes: the surgeon revised all medacta product on 14 march 2017 and the surgery was completed successfully.On 17 march 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision of cup, head and liner occurred 3 years after primary tha in a grossly overweight (as visible in the images) patient.Radiographic images show the migration of the cup across the medial wall.On the femoral side, signs of stress shielding can be observed.The resection level of the femur is rather low; the reasons for this choice are not known but this can have contributed to make the fixation of this stem more difficult, given also the patient's weight.Postoperative images are not available, so the initial cup position and acetabular preparation cannot be assessed.There are no indications of a defective device being the responsible agent for this failure.Batch review performed on 05 april 2017.(b)(4).

Event Description

Revision surgery scheduled due to cup protruding into acetabulum.The surgeon plans to revise the cup, head and liner.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 50
• Type of Device: ACETABULAR 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
• MDR Report Key: 6463871
• MDR Text Key: 71888010
• Report Number: 3005180920-2017-00157
• 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
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 134942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2013
• 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