MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO Ø 48; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.45.0048
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Involved implants lots are not available up today, no review of the related documentation could have been performed.
Event or Problem Description
On april 2nd we were informed about a revision performed on april 23rd, 2 months from the primary due to hip dislocation (head from liner).The cup was not seated sufficiently, anteverted to 45 degrees and acetabular appearing under-reamed.Revision surgery has been performed with post/lateral approach, no infection has been detected and the patient was elected to leave the stem and the head in situ.Poly, cup and one screw were removed.Revision surgery completed successfully.
Additional Manufacturer Narrative
Batch review performed on 29 may 2019: lot 182553: (b)(4) items manufactured and released on 21-jun-2018.Expiration date: 2023-06-13.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.Additional implants involved: liner: cc e cc light 01.26.3239hct flat pe hc liner ø 32 / c (k120531), lot 182621: (b)(4) items manufactured and released on 26-jul-2018.Expiration date: 2023-07-10.No anomalies found related to the problem.To date, 121 items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115), lot 180532: (b)(4) items manufactured and released on 12-jul-2018.Expiration date: 2023-06-26.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.

• Brand Name: CUP: VERSAFITCUP CC TRIO Ø 48
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8573531
• Report Number: 3005180920-2019-00327
• Device Sequence Number: 19456618
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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: 2019
• 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): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2023
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 182553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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