MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52

Model Number	01.26.45.1152
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 may 2020 lot 184697: (b)(4) items manufactured and released on 27-sep-2018.Expiration date: 2023-09-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Oher devices involved in the event ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 28 size m 0 lot.187071 (k112115) batch review performed on 28 may 2020: lot 187071: (b)(4) items manufactured and released on 06-dec-2018.Expiration date: 2023-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Stem: amistem-h prox.Coat.01.18.172 amistem-h proximal coating std stem #2 lot.170857 (k161635).Batch review performed on 28 may 2020: lot 170857: (b)(4) items manufactured and released on 21-apr-2017.Expiration date: 2022-04-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Liner: cc e cc light 01.26.2844hct flat pe hc liner 28 / e lot.181142 (k103352).Batch review performed on 28 may 2020: lot 181142: (b)(4) items manufactured and released on 29-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: 1 year after primary cementless tha the cup is found to be loose and requires revision.At surgery, according to report, the presence of infection has been verified, and therefore we should ascribe the cause for loosening to the intervened infection.
Event or Problem Description
Loose cup has been identified through a spect ct, where the area at the cup was bright.Revision confirmed looseness.Infection has been detected intraoperatively (unknown pathogen), although punctation a week earlier showed no infection.Surgeon proceeded explanting all components leabing girdlestone hip temporarily.1 year and 2 months after primary.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10137535
• Report Number: 3005180920-2020-00315
• Device Sequence Number: 19412991
• Product Code: LZO
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: No Information
• Device Expiration Date: 09/13/2023
• Device Model Number: 01.26.45.1152
• Device Catalogue Number: 01.26.45.1152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/10/2020
• 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