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

Model Number	01.26.2856MHC
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 july 2021: lot 2005002: (b)(4) items manufactured and released on 29-july-2020.Expiration date: 2025-07-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other deice involved: batch review performed on 08 july 2021: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot 2001862: (b)(4) items manufactured and released on 01-july-2020.Expiration date: 2025-06-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2020, the patient came in reporting pain due to a fracture that was cause from falling.The surgeon cabled the fracture and revised the stem, head, and liner.The surgery was completed successfully.Presently, on (b)(6) 2021, the patient came in reporting pain due to a leg length discrepancy.The cause of the leg length discrepancy is unknown.The surgeon revised the medacta head and liner.The surgery was completed successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC 56/28
• Common Device Name: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12202535
• Report Number: 3005180920-2021-00612
• Device Sequence Number: 4868414
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 07/21/2021

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: 07/13/2025
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 2005002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/21/2021
• 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