MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 56; HIP CEMENTLESS SHELL

Catalog Number	01.26.45.1156
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2018: lot 160064: (b)(4) items manufactured and released on 04 april 2016.Expiration date: 2021-03-21.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.Visual inspection performed by r&d project manager on 23-oct-2018: the acetabular cup has signs of osteointegration (residual bone) deformation and scratches on the edge due to revision procedure; the femoral head has few tiny metal transfer scratches, and slight stem taper footprint inside the taper cavity; the acetabular ceramic liner has stem impingement sign.The revision is due excessive dimension of the shell that was causing pain, as stated by the surgeon.Hence, the revision cause it is not device related.Clinical evaluation performed by medical affairs director on oct 24, 2018: acetabular component revision occurred 2 years after implantation due to pain.According to the report, the cause of pain was an oversized shell.Preoperative x-rays are not available.No conclusion on the reason of choice of a large implant size can be drawn.
Event or Problem Description
About 2 years after primary the surgeon revised the patient hip because the cup implanted in primary surgery was too big.The size 56 cup was replaced with a size 52; the liner and the head were swapped, too.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 56
• Common Device Name: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7999373
• Report Number: 3005180920-2018-00817
• Device Sequence Number: 16193706
• Product Code: LZO
• UDI-Device Identifier: 07630030807916
• UDI-Public: 07630030807916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2021
• Device Catalogue Number: 01.26.45.1156
• Device Lot Number: 160064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 90