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

Catalog Number	01.12.033
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by r&d product manager on 08 may 2018.Revision due to aseptic loosening of the stem.Stem and head have been extracted coupled together.Femoral stem shows scratches on the neck due to extraction process.The hydroxyapatite layer missing on the stem indicates the contact and bone growth regions and vice versa.In this asymmetric configuration, it is possible to hypothesize the causes of aseptic loosening.Bone debris are still attached to the hydroxyapatite layer.Femoral head shows a metal scratch probably due to extraction process.Batch review performed on 09 may 2018; lot 162220: (b)(4) items manufactured and released on 30 june 2016.Expiration date: 2021-06-15 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 surgery performed due stem loosening after about 2 years from the primary.The stem was implanted in (b)(6) 2016 and the patient returned to the hospital with significant stem subsidence and stem loosening in (b)(6) 2018.The surgeon removed the stem and head using then a competitor revision system.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7506733
• Report Number: 3005180920-2018-00323
• Device Sequence Number: 1438770
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 05/11/2018

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: 06/15/2021
• Device Catalogue Number: 01.12.033
• Device Lot Number: 162220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/11/2018
• 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: 73 YR