MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48

Model Number	01.26.45.0048
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-nov-2019.Lot 1901411: 200 items manufactured and released on 02-may-2019.Expiration date: 2024-04-21.No anomalies found related to the problem.To date, 144 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Acetabular wall bone fracture during cup positioning.A cemented cup was used to complete the surgery.
Additional Manufacturer Narrative
On 15-january-2020 we become aware that the device involved in this case was no longer available.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9346912
• Report Number: 3005180920-2019-00968
• Device Sequence Number: 16827782
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 04/21/2024
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 1901411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 01/27/2020
• 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: Other
• Patient Age: 82 YR