MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28; ACETABULAR DOUBLE MOBILITY LINER

Model Number	01.26.2856M
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 december 2020 lot 092229: (b)(4) items manufactured and released on 5-oct-2009.Expiration date: 2014-08-31.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 2016.Clinical evaluation performed by medical affairs director ten years after primary uncemented double mobility tha, the patient reports leg length difference.It's possible that the non-medacta stem has subsided, but this cannot be verified because no xray history is available.At the pre-revision xrays, however, the cup does not look like having undergone migration.The medacta dm liner was exchanged as per routine procedure, but there is no indication that it was faulty or non-performing adequately.
Event or Problem Description
The patient came in after 10 years and 11 months reporting a leg length discrepancy (the cause is unknown).The surgeon revised the non-medacta head and the medacta liner with a non-medacta head and a medacta liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 56/28
• Common Device Name: ACETABULAR DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11176028
• Report Number: 3005180920-2021-00051
• Device Sequence Number: 16743583
• Product Code: MEH
• UDI-Device Identifier: 07630030807404
• UDI-Public: 07630030807404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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: 08/31/2014
• Device Model Number: 01.26.2856M
• Device Catalogue Number: 01.26.2856M
• Device Lot Number: 092229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/15/2021
• 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: 68 YR
• Patient Weight: 109