MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.12.035
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 26 june 2020 lot 132371: (b)(4) items manufactured and released on 02-sep-2013.Expiration date: 2018-07-30.No anomalies found related to the problem.No anomalies found related to the problem.To date, 43 items of the same lot have been already sold without any other similar reported event.Clinical evaluation: 7 years after primary cementless tha the proximal part of the stem is surrounded by extensive osteolysis, causing some pain.The stem is removed and there is a strong suspect of infection, although we have no final confirmation to date.No evident signs of wear on the pe insert.Having only one projection it is difficult to judge cup anteversion and evaluate possibility of neck impingement due to position, but it seems very unlikely.Infection is the most likely cause for this revision.
Event or Problem Description
6 years and 6 months after the primary surgery the surgeon saw osteolysis around the stem and the patient had some pain.The surgeon decides to remove the implants and takes the liquid for analysis to confirm if there was an infection(results of the test not available).

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10282569
• Report Number: 3005180920-2020-00412
• Device Sequence Number: 485099
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: No Information
• Device Expiration Date: 07/30/2018
• Device Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 132371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/16/2020
• 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 Weight: 69