MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; CEMENTLESS STEM

Catalog Number	01.12.034
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 june 2019: lot 101025: (b)(4) items manufactured and released on 26-mag-2010.Expiration date: 2015-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Additional device involved in the complaint: cup: versafitcup cc light 01.26.52mbtl acetabular shell cc light ø 52 (item not registered in the usa) lot.100734: (b)(4) items manufactured and released on 08-jun-2010.Expiration date: 2015-04.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
Revision surgery planned on (b)(6) 2019, nine years after the primary due to cup and stem loosening (not confirmed by the surgeon).More info would be available after revision.
Additional Manufacturer Narrative
Batch review performed on 23 july 2019: lot 071446: (b)(4) items manufactured and released on 12.08.2007.Expiration date: 2012-06.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.Clinical evaluation performed by r&d project manager: from the received pieces it was noted that the stem with almost all the coating absorbed; some signs of removal were present both in the stem neck and in the acetabular shell.From the received parts it is not possible to determine the root cause of the event.Additional implant involved in the event, batch review performed on 23 july 2019 cup: versafitcup cc light 01.26.52mbtl acetabular shell cc light ø 52 lot.062378 lot 062378: (b)(4) items manufactured and released on 13.03.2007.Expiration date: 2012-02.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.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764336
• Report Number: 3005180920-2019-00545
• Device Sequence Number: 14159098
• Product Code: JDI
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• 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,Followup
• Report Date (Section B): 07/31/2019

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: 06/30/2012
• Device Catalogue Number: 01.12.034
• Device Lot Number: 071446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 07/31/2019
• 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
• Patient Age: 81 YR