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

Model Number 01.26.48MB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 03/03/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 312191452
• Report Number: 3005180920-2023-00194
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2008
• 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
• Patient Sex: Female