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 Code	Joint Disorder (2373)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 april 2018.(b)(4).Other implants involved: liner: cc e cc light hct flat pe hc liner ø 36 / e reference 01.26.3644 (k120531).(b)(4).Mectacer biolox delta ceramic ball head 12/14 ø 36 size l + 4 reference 01.29.210 ( k112115) (b)(4).Moreover, on 26 march 2018, the supplier of the ball head send us an investigation: the component properties and the microstructure as obtained from the quality documents fulfill the requirements as specified at the time of production.There are no indications of any pre-existing material defect or non-conformities regarding sterilisation.Due to a lack of ceramic parts further investigations cannot be done.Clinical evaluation performed by medical affairs director on 23 march 2018.Hip revision surgery occurred 5 months after primary cementless tha due to dislocation.Radiographic images provided show suboptimal acetabular shell position.The reason of this choice cannot be assessed on the basis of only postoperative radiographs.It is not known if the cup migrated after initial positioning or this was the original configuration.There is no reason to suspect a faulty device.
Event or Problem Description
On 08 march 2018 medacta's sales representative has been informed by the surgeon that a revision surgery will be necessary due to implant dislocation.Additional information received on 21st march 2018 by sales representative: the cup inlay and head have been removed.The explanted implants are not available.It was not an implant failure but wrong positioning of the cup ( too much anteversion and inclination).The revision was due to bad cup position in primary.

• 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, 6874 ; SZ 6874
• MDR Report Key: 7402536
• Report Number: 3005180920-2018-00210
• Device Sequence Number: 1216642
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 52 YR
• Patient Weight: 70