MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 52

Model Number	01.26.52MB
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-feb-2020.Lot 083736: 46 items manufactured and released on 25-feb-2009.Expiration date: 31.01.2014.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in reporting pain, and the surgeon observed that the patient's posterior wall was worn away after about 11 years from the primary surgery.The surgeon replaced the posterior wall, added an augment and revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9744766
• Report Number: 3005180920-2020-00103
• Device Sequence Number: 2456144
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 01/31/2014
• Device Model Number: 01.26.52MB
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 083736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/24/2020
• 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: Required Intervention
• Patient Age: 55 YR