MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC ACETABULAR INSERT; ACETABULAR PE LINER

Catalog Number	01.26.3239HCT
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018 it was communicated that the cu was too anteverted, malpositioned during the primary surgery.Batch reviews performed on 30 july 2018: lot 174483: (b)(4) items manufactured and released on 19 october 2017.Expiration date: 2022-10-04.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.Batch review for mectacer biolox delta ceramic ball head 12/14 ø 32 size m ref.01.29.205 lot.164976 (k112115): (b)(4) items manufactured and released on 04 november 2016.Expiration date: 2021-10-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Batch review forversafitcup cc trio acetabular shell ø 48 ref.01.26.45.0048 lot.151056 (k103352): (b)(4) items manufactured and released on 26 may 2015.Expiration date: 2020-04-30.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
The patient came in complaining of pain.The surgeon determined that the patient had dislocated.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP CC ACETABULAR INSERT
• Common Device Name: ACETABULAR PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734730
• Report Number: 3005180920-2018-00600
• Device Sequence Number: 1018871
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 10/04/2022
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 174483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2018
• Initial Report FDA Received Date: 07/31/2018
• 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