MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54

Catalog Number	01.26.45.0054
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 146986: (b)(4) items manufactured and released on 02 december 2014.Expiration date: 2019-10-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other devices involved: liner: cc e cc light flat pe hc liner ø 36 / e reference 01.26.3644hct (k120531).Lot 148362: (b)(4) items manufactured and released on 27 april 2015.Expiration date: 2020-03-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold with 1 similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0 reference 01.29.209 (k112115).Lot 150458: (b)(4) items manufactured and released on 13 may 2015.Expiration date: 2020-03-31.No anomalies found related to the issue.To date, all the items of the same lot have been already sold with 1 similar reported event.Cancellous bone screw flat head ø 6,5 l 30 reference 01.26.65.30 (k103352).Lot 147785: (b)(4) items manufactured and released on 03 march 2015.Expiration date: 2020-01-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.K103352.Cancellous bone screw flat head ø 6,5 l 20 reference 01.26.65.20 (k103352).Lot 122778: (b)(4) items manufactured and released on 02 august 2012.Expiration date: 2017-08-31.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.Quadra-h 01.12.022 cementless, ha coated std stem size 2 (k082792).Lot 147635: (b)(4) items manufactured and released on 17 february 2015.Expiration date: 2020-01-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery planned for (b)(6) 2019 due to pain, 3 years and a half after the primary surgery.The surgeon is planning to remove the versafit cup, liner and screws and will revise the stem if required.
Additional Manufacturer Narrative
Update 9 jan from the sales representative: the revision surgery was successfully completed today and the surgeon removed all the implants due to pain.The surgeon advised that there was slight loosening of the implants which he felt was the cause of the pain.X-rays and explants are not available.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217186
• Report Number: 3005180920-2018-01055
• Device Sequence Number: 1631496
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 10/31/2019
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 146986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/07/2019
• 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
• Patient Age: 68 YR