MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 48; HIP ACETABULAR CUP

Model Number	01.26.48MB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 march 2023: lot 081312: (b)(4) items manufactured and released on 10-oct-2008.Expiration date: 2013-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Additional components involved: ball heads: mectacer 38.39.7175.255.00 biolox forte ceramic ball head 12/14 ø 28 size m 0 (usa) (k073337) lot 081264: (b)(4) items manufactured and released on 28-apr-2008.Expiration date: 2013-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Liner: versafitcup dm 01.26.2848m double mobility liner ø 48/28 (k083116) lot 083746: (b)(4) items manufactured and released on 04-mar-2009.Expiration date: 2013-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient came in reporting pain and the cause is unknown.At about 13 years and 11 months post primary the surgeon revised the medacta cup and liner with a competitor cup and liner, and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Common Device Name: HIP ACETABULAR CUP
• 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: 16633975
• Report Number: 3005180920-2023-00194
• Device Sequence Number: 12291491
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/29/2023

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: 08/31/2013
• Device Model Number: 01.26.48MB
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 081312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2008
• 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