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

Catalog Number	01.26.50MB
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 5 july 2019: lot 172680: (b)(4) items manufactured and released on 15 november 2017.Expiration date: 2022-11-07.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.Clinical evaluation performed by medacta medical affairs director: cup mobilization occurred few days after a revision surgery in a (b)(6) year old, obese ((b)(6)) patient.This is the second acetabular loosening occurred in the same patient probably suggesting the presence of unknown conditions or comorbidities that can hinder bone on-growth and component fixation.Implant position before mobilization cannot be assessed on the basis of information provided.The reason of this event cannot be determined.Visual inspection performed by medacta hip r&d project manager: analyzing the cup, no evident signs of defects device related were found: some fibrotic and bone tissue was already present in the macrostructures, evident signs of a beginning of a correct osseo-integration.It is possible that the position of the cup or the particular conditions of the bone did not allow the correct stability of the cup in the acetabulum, but from the received information it is not possible to determine with certaninty the root cause of the event.
Event or Problem Description
Second revision surgery performed for cup loosening one week after the previous revision surgery.The cup, liner and ball head have been revised.The first revision surgery has been performed 3 years after the primary surgery due to acetabulum instability (apricot cup mobilization) and stem loosening.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 50
• Common Device Name: UNCEMENTED HIP SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8826041
• Report Number: 3005180920-2019-00598
• Device Sequence Number: 19476903
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• 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
• Report Date (Section B): 07/25/2019

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: 11/07/2022
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 172680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/25/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 120