MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 52; HIP ACETABULAR SHELL

Catalog Number	01.26.52MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 june 2019: lot 114426: (b)(4) items manufactured and released on 03-gen-2012.Expiration date: 2016-11.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.Other devices were involved in the complaint.Batch review performed on 25 june 2019: liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 lot 113646 (k092265): (b)(4) items manufactured and released on 16-nov-2011.Expiration date: 2016-10.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 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot 115748 (k112115): (b)(4) items manufactured and released on 15-feb-2012.Expiration date: 2016-12.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
Revision surgery performed after 7 years from the primary due to pain and the cause of the pain is unknown.The surgeon revised the head, cup, and liner and the surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL CC Ø 52
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8780218
• Report Number: 3005180920-2019-00559
• Device Sequence Number: 19499721
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 11/30/2016
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 114426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/11/2019
• 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