MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.12.034
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by r&d product manager on november 05, 2018 from visual investigation, it is not possible to determine a device related failure root cause.Hydroxyapatite (ha) layer has been absorbed almost completely during in situ time (except for few small aeas of residual ha).Clinical evaluation performed by medical affairs manager on november 09, 2018; stem and head revision surgery occurred 7 years after primary cementless total hip arthroplasty.According to the report, the patient was complaining about pain due to stem loosening.Aseptic loosening is a possible, literature described long-term adverse event after cementless hip replacement and causes are often unknown.The reason of this event cannot be determined.Batch review performed on 27 november 2018; lot 101076: (b)(4) stems produced and released on 16 june 2018.Expiration date: 2015-05-31; no anomalies found related to the problem.All stems belonging to this lot have been already sold with 1 other similar reported event.
Event or Problem Description
Revision surgery performed due to stem loosening (left side) causing proximal femoral pain after about 7 years.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8105809
• Report Number: 3005180920-2018-00952
• Device Sequence Number: 11262037
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• 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: 2011
• 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): 11/27/2018

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: 05/31/2015
• Device Catalogue Number: 01.12.034
• Device Lot Number: 101076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/27/2018
• 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 Weight: 85