MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28; HIP ACETABULAR LINER

Model Number	01.26.2854MHC
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 years and 9 months after the primary surgery, the patient came in reporting pain due to a loose cup.The cause of the loose cup is unknown.The surgeon revised the head, liner, and cup with additional screws.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19-oct-2022.Lot 103170: (b)(4) items manufactured and released on 03-dec-2010.Expiration date: 2015-oct-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28
• Common Device Name: HIP ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15680349
• Report Number: 3005180920-2022-00829
• Device Sequence Number: 6368904
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• 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): 10/27/2022

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: 10/31/2015
• Device Model Number: 01.26.2854MHC
• Device Catalogue Number: 01.26.2854MHC
• Device Lot Number: 102793
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2010
• 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