MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY LINER Ø 50/28

Model Number	01.26.2850M
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 december 2021.Lot 090898: (b)(4).Expiration date: 2014-04-30.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in for a post-op appointment and the surgeon decided to revise the patient following suspected liner wear.The surgeon revised the competitor's head and medacta poly 12 years and 5 months after primary.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DM 01.26.2850M DOUBLE MOBILITY LINER Ø 50/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13078037
• Report Number: 3005180920-2021-01022
• Device Sequence Number: 5630639
• Product Code: MEH
• UDI-Device Identifier: 07630030807275
• UDI-Public: 07630030807275
• 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: 2009
• 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): 12/23/2021

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: 04/30/2014
• Device Model Number: 01.26.2850M
• Device Catalogue Number: 01.26.2850M
• Device Lot Number: 090898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female