MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.33SN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 09 february 2018: late infection in cementless tha, 1 year after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Batch review performed on 19 february 2018; lot 146295: (b)(4) items manufactured and released on 11 october 2014.Expiration date: 2019-09-30.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.Versafitcup acetabular shell ø 56 reference 01.26.56mb (k083116); lot 155804: (b)(4) items manufactured and released on 25 february 2016.Expiration date: 2021-02-09.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.Mectacer biolox delta ceramic ball head 12/14 ø 28 size m 0 reference 01.29.202 (k112115); lot 162717: (b)(4) items manufactured and released on 24 august 2016.Expiration date: 2021-07-27.No anomalies found related to the problem.To date, 76 items of the same lot have been already sold without any similar reported event.(b)(4) versafitcup dm double mobility hc liner ø 56/28 reference 01.26.2856mhc (k092265); lot 160075: (b)(4) items manufactured and released on 10 march 2016.Expiration date: 2021-02-24 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 due to signs of infection 1 year and 2 months after primary.Cup and liner replaced with medacta hardware, while stem and head with another company's products.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed on 27 february 2018 by r&d product manager: the stem was completely scratched on the proximal part, while several grooves were applied on the intradox region of the stem, indicating a difficult removal of the stem from the femur.The ha coating was still present inside some proximal macrostructures.The cup did not show any particular sign.The liner was yellowed on the articulating part, but no other particular signs were noticed on the liner.From the received parts it is not possible to determine the root cause of the event.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7281754
• Report Number: 3005180920-2018-00067
• Device Sequence Number: 11024076
• Product Code: JDI
• UDI-Device Identifier: 07630030802737
• UDI-Public: 07630030802737
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 09/30/2019
• Device Catalogue Number: 01.12.33SN
• Device Lot Number: 146295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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