MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 52

Catalog Number	01.26.52MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on (b)(6) 2018 re-revision of acetabular cup in cementless tha.No documentation is available to analyze possible causes.In the post-revision image, a very evident osteopenic area is visible cranial to the acetabular cup, causes unknown, which probably undermined stability of the previous cup.No further comments can be expressed with the information at hand.Batch review performed on (b)(6) 2018.Lot 148343: (b)(4) items manufactured and released on (b)(6) 2015.Expiration date: 03/31/2020.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.Versafitcup dm double mobility hc liner ø 52/28 reference 01.26.2852mhc (k092265) lot 162321: (b)(4) items manufactured and released on (b)(6) 2016.Expiration date: 06/29/2021.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.
Event or Problem Description
The patient had a primary case on (b)(6) 2015.On (b)(6) 2017 the patient came in complaining of instability due to stem subsidence.The surgeon revised the patient with another company's stem and head and a medacta liner [(b)(4)].On (b)(6) 2018 the patient came in complaining of pain.The cause is unknown.The surgeon removed the cup (implanted on (b)(6) 2015) and the liner (implanted on (b)(6) 2017) and the other company's head with another company's product.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7360998
• Report Number: 3005180920-2018-00170
• Device Sequence Number: 16407102
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

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: 03/31/2020
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 148343
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/22/2018
• 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