MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø56; HIP CEMENTLESS SHELL

Model Number	01.26.56MB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-apr-2023: lot 090245: 26 items manufactured and released on 06-may-2009.Expiration date: 2014-03-31.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.Additional device involved batch review performed on 11-apr-2023 liner: versafitcup dm 01.26.2856m double mobility liner ø 56/28 (k083116) lot 090257: 36 items manufactured and released on 31-mag-2009.Expiration date: 2014-03-31.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.Clinical evaluation performed by medacta medical affairs director: revision 13 years and 4 months after the primary surgery due to a fractured acetabulum.The patient came in reporting pain due to a fractured acetabulum and the cause is unknown.With the information at hand the reason of this failure cannot be determined.
Event or Problem Description
At about 13 years and 4 months after the primary surgery, the patient came in reporting pain due to a fractured acetabulum and the cause is unknown.The surgeon plated the fracture, revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager from the received parts, no particular signs related to the event were noticed; the liner was signed on its surface, probably occurred during the revision, and the ceramic head did not show any particular sign, except for the inner signs due to the coupling with the stem.From the received parts and information it is not possible to determine the root cause of the event.Note: the acetabular shell was not sent back for analysis, the scrub tech made only the liner and head available to the sales rep.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø56
• Common Device Name: HIP CEMENTLESS SHELL
• 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: 16814939
• Report Number: 3005180920-2023-00316
• Device Sequence Number: 5733517
• Product Code: MEH
• UDI-Device Identifier: 07630030808173
• UDI-Public: 07630030808173
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 03/31/2014
• Device Model Number: 01.26.56MB
• Device Catalogue Number: 01.26.56MB
• Device Lot Number: 090245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2009
• 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: Unknown