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

Catalog Number 01.26.50MB

Device Problems Loose or Intermittent Connection (1371); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

On 22 january 2016, the medical affairs director performed a clinical evaluation and commented as follows: for unknown reasons, this cup was placed very deep inside the acetabular cavity, with an extremely thin bone wall remaining before the cup definitely migrated into the abdomen.The deep cup was probably a surgical situation because an extra long head has apparently been used, so this should not be a case of cup migration.A large radiolucency is visible around the cup and there is no x-ray history that could help understand how it developed.However, the cup looks definitely loose and unable to sustain physiological loads, and revision with a large diameter implant was surely the correct choice.Batch review performed on 02 february 2016.Lot 123268: (b)(4) items manufactured and released on 27 november 2012.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, all (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient has been experiencing pain in her hip.The surgeon took x-rays and saw that the cup was loose.The surgeon removed the cup and felt the initial cup was undersized.The surgery was completed successfully.X-rays will be attached.The explant will not be returned.

Manufacturer Narrative

On 05 april 2016 it was prepared a final report with the information already submitted in the initial report.On 11 april 2016 the report was sent to the initial reporter and the case was closed.

• 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 ; 91 6966060
• MDR Report Key: 5412827
• MDR Text Key: 37544686
• Report Number: 3005180920-2016-00026
• 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: 05/02/2016

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: 10/31/2017
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 123268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2012
• 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
• Patient Age: 49 YR