MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C; ACETABULAR PE HC LINER

Model Number	01.26.2839HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 march 2021: lot 156954: (b)(4) items manufactured and released on 08-apr-2016.Expiration date: 2021-03-22.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 since 1-jan-2017.Additional implant involved: ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot.162046.Batch review performed on 17 march 2021: lot 162046: (b)(4) items manufactured and released on 11-may-2016.Expiration date: 2021-04-14.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 since 1-jan-2017.Additional implant involved: cup: versafitcup cc trio 01.26.45.1148 acetabular shell cc trio no-hole ø 48 (k122911) lot.161601.Batch review performed on 06 april 2021: lot 161601: (b)(4) items manufactured and released on 20-jun-2016.Expiration date: 2021-06-08.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 1-jan-2017.Clinical evaluation performed by medical affairs manager: acetabular component revision performed 4.5 years after cementless total hip arthroplasty in a (b)(6) year old woman.Although no lateral projection is available, in the radiographic image provided the position of the acetabular cup appears to be inadequate.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.In these conditions, it is very likely that part of the femoral stem may impinge with the acetabular rim and therefore dislocation occurs.The cause of dislocation should be defined as cup position.The cause for such cup position is unknown.
Event or Problem Description
Revision surgery 4 years and 6 months after primary for hip anterior luxation.The surgeon revised successfully the cup, inlay and head with double mobility versacem and biolox option 28 xl.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C
• Common Device Name: ACETABULAR PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11618156
• Report Number: 3005180920-2021-00265
• Device Sequence Number: 3866487
• Product Code: LZO
• UDI-Device Identifier: 07630030807091
• UDI-Public: 07630030807091
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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: 03/22/2021
• Device Model Number: 01.26.2839HCT
• Device Catalogue Number: 01.26.2839HCT
• Device Lot Number: 156954
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/06/2021
• 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
• Patient Weight: 75