MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSACEM DOUBLE MOBILITY HC LINER 56/28; CEMENTLESS STEM

Model Number	01.26.2856MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04.Aug.2021: lot 2009655: 120 items manufactured and released on 4-nov-2020.Expiration date: 2025-10-12.No anomalies found related to the problem.To date, 77 items of the same lot have been sold without a similar reported event.Additional items involved in the event, batch review performed on 04.Aug.2021: cup: versacem 01.27.56cmb double mobility metal back cemented 56 lot.1900897 (item not registered in usa).Lot 1900897: 19 items manufactured and released on 23-may-2019.Expiration date: 2024-05-12.No anomalies found related to the problem.To date, 10 items of the same lot have been sold without a similar reported event.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 28 size m 0 lot.Unknown (k112115).
Event or Problem Description
2 months after the primary surgery the surgeon removed the implants due to infection.The cup, liner and head were medacta while the stem was a competitor product.The ball head lot is unknown.

• Brand Name: LINER: VERSACEM DOUBLE MOBILITY HC LINER 56/28
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12405771
• Report Number: 3005180920-2021-00690
• Device Sequence Number: 5304505
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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: 10/12/2025
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 2009655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 09/01/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 83