MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP VERSAFITCUP ACETABULAR SHELL Ø 58; HIP ACETABULAR SHELL

Catalog Number	01.26.58MB
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 february 2019: lot 165688: (b)(4) items manufactured and released on 25-jan-2017.Expiration date: 2022-01-10.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.An additional item was involved in the complaint.Liner: versafitcup dm 01.26.2858mhc double mobility hc liner ø 58/28 lot.176667 (k092265): (b)(4) items manufactured and released on 16-jan-2018.Expiration date: 2023-01-01.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.
Event or Problem Description
Revision surgery after one month and half from the primary due to signs of infection (pathogen unknown).The cup and liner have been explanted (an antibiotic spacer was implanted).The surgery was completed successfully.

• Brand Name: CUP VERSAFITCUP ACETABULAR SHELL Ø 58
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8377329
• Report Number: 3005180920-2019-00105
• Device Sequence Number: 3014245
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• 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: 2018
• 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): 02/28/2019

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: 01/10/2022
• Device Catalogue Number: 01.26.58MB
• Device Lot Number: 165688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/28/2019
• 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