MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.48MB ACETABULAR SHELL Ø 48; CEMENTLESS ACETABULAR CUP

Catalog Number	01.26.48MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: cup and liner revision surgery 8 months after cementless dual mobility total hip arthroplasty due to pain.During surgery cup fixation was confirmed, and no clue about the origin of the pain was found.From the scarce documentation received, we are unable to determine the cause for this problem.No specific complaint describing a defect in the implants was filed.Batch review performed on 07 february 2019: lot 175880: (b)(4) items manufactured and released on 31-jan-2018.Expiration date: 2023-01-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional components involved: liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265), lot 177524: (b)(4) items manufactured and released on 20-feb-2018.Expiration date: 2023-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5 (k112115), lot 174694: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-11.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 7 months after primary the surgeon revised the patient cup, liner and ceramic head.The surgeon suspected of cup loosening but was not confirmed during surgery.Anyway the surgeon performed cup, liner and ball head swap.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP 01.26.48MB ACETABULAR SHELL Ø 48
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8319900
• Report Number: 3005180920-2019-00036
• Device Sequence Number: 2358064
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: 01/22/2023
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 175880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/08/2019
• 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