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

Catalog Number	01.26.52MB
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 jun 2019: lot 050751: (b)(4) items manufactured and released on 09-nov-2005.Expiration date: 2010-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implants involved: liner: versafitcup dm 01.26.2852m double mobility liner ø 52/28 (k083116) lot 051580: (b)(4) items manufactured and released on 30-nov-2005.Expiration date: 2010-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857) lot 070959: (b)(4) items manufactured and released on 19-jun-2007.Expiration date: 2012-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
On (b)(6) 2019 we were informed about a revision surgery performed on the following day, after about 12 years from the primary, due to cup loosening and luxation of the head from the liner.No information about the head, if ceramic or crco.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8673857
• Report Number: 3005180920-2019-00440
• Device Sequence Number: 2039539
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 06/06/2019

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: 08/31/2010
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 050751
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/06/2019
• 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