MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50; HIP ACETABULAR SHELL NO HOLE

Catalog Number	01.26.45.1150
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 jun 2019.Lot 165401: (b)(4) items manufactured and released on 11-nov-2016.Expiration date: 2021-11-01.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.One other device was involved in the complaint stem: amistem h 01.18.143 ha coated lat stem #3 lot.165826 (k093944): (b)(4) items manufactured and released on 19-jan-2017.Expiration date: 2022-01-08.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.Clinical evaluation performed by medical affairs director: less than 2 years after primary cementless tha a revision is performed, for unspecified reasons.The stem could not be extracted.What appears to be a distal femoral fracture from the radiograph was judged by the surgeon not to be a reason for concern.The resection level is unusual and the shape of the bone at resection does not look normal, but we are unable to supply an explanation.According to report, the cementless components were well fixed to the bone, so we do not suspect a device malfunction.
Event or Problem Description
Revision surgery performed after 1 year and 8 months from the revision due to pain (no bone fracture, no stem loosening despite radiolucencies).It was impossible to extract the stem using the stem extractor (kalberer) and the surgeon decided to leave the stem in place.The ceramic ball head, acetabular shell, and liner have been revised.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Common Device Name: HIP ACETABULAR SHELL NO HOLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8699595
• Report Number: 3005180920-2019-00467
• Device Sequence Number: 16648389
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: 11/01/2021
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 165401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: 55 YR
• Patient Weight: 106