MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.12.022
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed on 04 april 2018 by r and d product manager: implant image analysis does not show any sign of damage on the femoral stem.The hydroxyapatite coating has been completely adsorbed during in situ time.Further information will be provided upon visual inspection of the implant when available.Batch review performed on 13 april 2018: lot 121503: (b)(4) items manufactured and released on 22 june 2012.Expiration date: 2017-05-31.Clinical evaluation performed by medical affairs director on 20 april 2018 partial hip revision surgery (stem and head) occurred 5,5 years after primary cementless total hip arthroplasty in a (b)(6) woman.Radiographic images provided show the presence of signs of stress shielding and radiolucent lines in "gruen" zones 1, 2, 6 and 7 suggesting loosening of the stem.Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown.The reasons of this event cannot be determined.
Event or Problem Description
Revision surgery performed due to stem loosening (right side) after 6 years and 3 months from the primary.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7446811
• Report Number: 3005180920-2018-00253
• Device Sequence Number: 11204594
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 01.12.022
• Device Lot Number: 121503
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/20/2018
• 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: 64 YR
• Patient Weight: 58