MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 56; ACETABULAR HIP SHELL

Model Number	01.26.56MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 10 years and 11 months after primary due to hip infection.An antibiotic spacer has been implanted successfully.
Additional Manufacturer Narrative
Batch review performed on 19 november 2021: lot 103046: (b)(4) items manufactured and released on 08-nov-2010.Expiration date: 2015-09-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event since release on the market of the lot.Additional item involved in the event, batch review performed on 19 november 2021: liner: versafitcup dm 01.26.2856mhc double mobility hc liner ø 56/28 (k092265) lot.103053.Lot 103053: (b)(4) items manufactured and released on 29-oct-2010.Expiration date: 2015-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since release on the market of the lot.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 56
• Common Device Name: ACETABULAR HIP 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 12968415
• Report Number: 3005180920-2021-00965
• Device Sequence Number: 17286412
• Product Code: MEH
• UDI-Device Identifier: 07630030808173
• UDI-Public: 07630030808173
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 09/30/2015
• Device Model Number: 01.26.56MB
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 103046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown