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

Catalog Number	01.26.45.0052
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 august 2018; lot 172505: (b)(4) items manufactured and released on 12 september 2017.Expiration date: 2022-08-28; 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.Other devices involved: reference 01.26.3644hct (k120531) flat pe hc liner ø 36/ e; lot 172577: (b)(4) items manufactured and released on 14 august 2017.Expiration date: 2022-07-23.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.Reference 01.12.21sn (k082792) cementless, ha coated std stem # 1, short neck; lot 168107: (b)(4) items manufactured and released on 31 march 2017.Expiration date:2022-03-21; 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 01.25.031 (k080885) cocr ball head 12/14 ø 36 size m 0; lot 154625: (b)(4) items manufactured and released on 01 december 2015.Expiration date: 2020-11-17; 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.Clinical evaluation performed on 31 july 2018 by medical affairs manager infection in cementless tha, 1 year after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision due to infection 9 months after primary: abscess found.The patient started complaining about pain in (b)(6) 2018, after an urinary infection.At the lab there was no evidence of any germ.During revision the stem was not loose but the cup was loose and it was easily removed: all the implants have been removed and an cement spacer with antibiotics has been implanted.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793275
• Report Number: 3005180920-2018-00612
• Device Sequence Number: 1197615
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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: 08/28/2022
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 172505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• 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: 84 YR
• Patient Weight: 84