MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFTICUP CC TRIO ACETABULAR SHELL Ø 58; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.45.0058
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 17 nov 2017 the medical affairs made the following analysis: partial hip revision surgery (cup, head and liner) due to dislocation occurred during the first postoperative month.According to the report, the reason of this event is probably linked to a suboptimal component positioning during primary implantation.Dislocation may also be caused by insufficient soft tissue tension but it can hardly be caused by standard devices batch review performed on 30 november 2017: lot 170091: (b)(4) items manufactured and released on 18 may 2017.Expiration date: 2022-05-08.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.Versafitcup cc flat pe hc ø liner 36 / f ref.01.26.3648hct lot.172578 (k103352): (b)(4) items manufactured and released on 25 july 2017.Expiration date: 2022-07-06.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.Cocr ball head 12/14 ø 36 size m ref.01.25.031 lot.166598 (k080885): (b)(4) items manufactured and released on 18 january 2017.Expiration date: 2022-01-08.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 discomfort.The surgeon determined the patient had dislocated his hip, the patient was dislocating posteriorly.The cup was not anteverted enough.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• Brand Name: VERSAFTICUP CC TRIO ACETABULAR SHELL Ø 58
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7070539
• Report Number: 3005180920-2017-00712
• Device Sequence Number: 1004681
• Product Code: LZO
• UDI-Device Identifier: 07630030807800
• UDI-Public: 07630030807800
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 05/08/2022
• Device Catalogue Number: 01.26.45.0058
• Device Lot Number: 170091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/30/2017
• 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: 65 YR