MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 50; HIP ACETABULAR SHELL

Catalog Number	01.26.50MB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot: 166339: (b)(4) items manufactured and released on 25-jan-2017.Expiration date: 2022-01-10.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.Preliminary investigation performed by r&d project manager: base on pictures received is it possible to state the acetabular cup is covered in bio fluids and bone residuals.It is not possible to establish a certain event root cause.Clinical evaluation performed by medical affairs director: less than 1 year after hybrid primary tha, the cup mobilized and was revised.The only radiograph available is probably before revision, after cup loosening, so we cannot evaluate size and position of the cup after surgery.Though no scale references are shown, the patient seems to have very small femoral canals and small and shallow acetabulum, anatomical conditions that may hinder sound fixation and possibly limit range of movement prior to impingement, which seems to have occurred in this case and mobilized the cup.No reason to suspect a faulty device.
Event or Problem Description
On (b)(4) we were informed about a revision surgery performed on (b)(6) about 1 year after primary revision surgery performed for cup loosening.The surgeon believes the reason for implant loosening was due to the patient anatomy and combination of musculo-skeletal deformities.Some bonding visible on the rim of the cup.Some metallosis visible due to impingement on the trunnion of the xacta stem.Cup, liner and head swap performed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: dm shell shows signs of extraction and impingement on edge.Without femoral stem analysis (not received) it is not possible to define any failure root cause.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 50
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8802795
• Report Number: 3005180920-2019-00579
• Device Sequence Number: 343053
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/12/2019

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: 01/10/2022
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 166339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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