MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50

Catalog Number	01.26.45.0056
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 august 2018.Lot 176989: (b)(4) items manufactured and released on 14 february 2018 expiration date: 2023-02-05.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.Mectacer reference 01.29.206 (k112115) biolox delta ceramic ball head 12/14 ø 32 size l +4: lot 174709: (b)(4) items manufactured and released on 11 october 2017.Expiration date: 2022-10-03 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.Quadra-h reference 01.12.034 (k082792) cementless, ha coated lat stem size 4: lot 151877: (b)(4) items manufactured and released on 11 september 2015.Expiration date: 2020-08-24 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.Liner: cc e cc light reference 01.26.3248hcat (k103352) hooded pe hc fixed liner ø 32 / f : lot 170960: (b)(4) items manufactured and released on expiration date:2022-05-04 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.Reference 01.26.65.25 (k103352) cancellous bone screw, flat head ø 6,5 l 25: lot 176929:(b)(4) items manufactured and released on 23 november 2017.Expiration date: 2022-10-23 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.Lot 179026: (b)(4) items manufactured and released on 31 january 2018.Expiration date:2023-01-15 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 due to infection 2 months after primary surgery.Pathogen not available.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793266
• Report Number: 3005180920-2018-00611
• Device Sequence Number: 1468844
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 02/05/2023
• Device Catalogue Number: 01.26.45.0056
• Device Lot Number: 176989
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• 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: 57 YR
• Patient Weight: 70