MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1; CEMENTLESS HIP STEM

Catalog Number	01.12.031
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed on 09 march 2018 by medical affairs: partial hip revision surgery (stem and head) occurred 6 years after primary cementless total hip arthroplasty.Radiographic images provided show the presence of osteolytic areas and the stem looks thoroughly detached from bone.The reasons cannot be determined with the information at hand, but it may be worth investigating what kind of adverse reaction took place.It seems to have originated proximally and the stem locked distally before detaching completely, but the cause is not known.Batch review performed on 26 march 2018; lot 120284: (b)(4) items manufactured and released on 06 april 2012.Expiration date: 2017-02-28; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Preliminary investigation performed by r&d product manager on 27 march 2018: from the image analysis is not possible to evaluate eventual implant failure causes attributed to the implant.However, few pits are visible on the posterior side and a particular undefined texture is visible on the proximal lateral and medial distal side of the stem.Slight taper trunnionosis seems visible on the medial side of cone taper.Investigation on the actual explant seems necessary.
Event or Problem Description
Revision surgery performed due to stem loosening.Quadra-h was replaced with a quadra-c.
Additional Manufacturer Narrative
Visual inspection performed on 30 april 2018 by r&d product manager.The stem appeared with the coating in the proximal area, showing a possible non proper integration with the bone, even if some bone was present in the macrostructures of the proximal area but with the received information it is not possible to determine the root cause of the event.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7380961
• Report Number: 3005180920-2018-00195
• Device Sequence Number: 19095799
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 02/28/2017
• Device Catalogue Number: 01.12.031
• Device Lot Number: 120284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 106