MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8; CEMENTLESS COATED HIP STEM

Catalog Number	01.12.028
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 december 2017.Lot 061520: (b)(4) items manufactured and released on 23 november 2006.Expiration date: 2011-10-31 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
9 years after primary revision surgery for stem loosening.The surgeon revised all the implant successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager on (b)(6) 2018: the stem showed the coating absorbed, except for a small area in the metaphyseal part.Scratches and signs of removal were noticed on the neck; no other particular signs were noticed and, from the received parts, it is not possible to determine the root cause of the event.On (b)(6) 2018 the medical affairs director made the following analysis: ten years after primary cementless tha the femoral stem is found loose and replaced, along with the acetabular cup.According to report, "a lot of connective tissue" was found in the proximal femur area.This is only partially visible in the one xray supplied.The tribological pairing is ceramic on ceramic so it is unlikely that an osteolytic reaction was originated by particulate debris.No signs of abnormal wear have been described.The cup is implanted with very little or no anteversion, which probably caused frequent low-load impingement between the femoral neck and the insert rim (typically, in high flexion plus adduction, such as in leg-crossing position).This is witnessed by a small rounded mark on the stem neck, exactly correspondent to the rim of the cup.While the amount of wear induced by this impingement is probably negligible, the torsional load applied to the stem may have contributed causing the fibrous tissue development and the long-term loosening.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8
• Common Device Name: CEMENTLESS COATED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7121400
• Report Number: 3005180920-2017-00748
• Device Sequence Number: 1410770
• Product Code: JDI
• UDI-Device Identifier: 07630030802096
• UDI-Public: 07630030802096
• 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: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 10/31/2011
• Device Catalogue Number: 01.12.028
• Device Lot Number: 061520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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