MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28; HIP DOUBLE MOBILITY HC LINER

Model Number 01.26.2856MHC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 11-may-2023.Lot 2105782: (b)(4) items manufactured and released on 18-jun-2021.Expiration date: 2026-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: cup: mpact 01.32.156mb double mobility acetabular shell ø56 (k143453) lot 2101494: (b)(4) items manufactured and released on 06-jul-2021.Expiration date: 2026-06-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot 2104416: (b)(4) items manufactured and released on 06-jul-2021.Expiration date: 2026-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 1 year and 1 month after the primary surgery, the patient came in reporting pain and the cause is unknown.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28
• Type of Device: HIP DOUBLE MOBILITY HC 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: 17029895
• MDR Text Key: 316296992
• Report Number: 3005180920-2023-00397
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 2105782
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention