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

Catalog Number	01.12.035
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 june 2018.Lot 155691: (b)(4) items manufactured and released on 28 january 2016.Expiration date: 2021-01-17.No anomalies found related to the problem.To date, no similar events have been reported on items of the same lot.Clinical evaluation performed by medical affairs director on october 17, 2018.Partial hip revision surgery occurred 1 year and 5 months after primary cementless total hip arthroplasty in (b)(6).According to the information received, the stem was removed due to mobilization.With such a short follow up, it is conceivable that this stem was never able to achieve osseointegration, for reasons that we cannot determine but that are most probably to be sought in the individual patient reaction to the implanted device.Sometimes a so called "silent" infection is thought to be responsible for these early loosenings, but we have no information on this hypothesis.
Event or Problem Description
About 1 year and 5 months after primary the surgeon revised the patient for stem mobilization.The surgeon revised the stem successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5 L
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7984648
• Report Number: 3005180920-2018-00803
• Device Sequence Number: 1434258
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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: 01/17/2021
• Device Catalogue Number: 01.12.035
• Device Lot Number: 155691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/19/2018
• 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: 71 YR
• Patient Weight: 110