MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMD; HIP SHELL DOUBLE MOBILITY LINER

Catalog Number	01.26.2848M
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 13 years and 11 months after the primary surgery, the surgeon performed a washout and revised the liner and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 november 2023: lot 091602: (b)(4) manufactured and released on 01-sep-2009.Expiration date: 2014-jul-31.No anomalies found related to the problem.To date, 34 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 11 december 2023: cocr 01.25.012 cocr ball head 12/14 28 size m 0 (k072857) lot 091341: (b)(4) manufactured and released on 18-aug-2009.Expiration date: 2014-jun-30.No anomalies found related to the problem.To date, 79 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER 28/DMD
• Common Device Name: HIP SHELL DOUBLE MOBILITY 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18301138
• Report Number: 3005180920-2023-00999
• Device Sequence Number: 3613379
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• 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: 2023
• 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): 12/11/2023

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: 07/31/2014
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 091602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2009
• 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