MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK; CEMENTLESS HIP STEM

Model Number	01.12.31SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 march 2021.Lot 115217: (b)(4) items manufactured and released on 28-march-2012.Expiration date: 2017-02-28.No anomalies found related to the problem to date, all items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.Clinical evaluation performed by medical affairs director.6 years after primary cementless tha the femoral stem gets loose, with evident signs of stress shielding.The pre-revision xray is not available and therefore no comment can be made as to the position or fit of the stem.We must therefore conclude that this is a case of aseptic loosening, a possible complication of total hip arthroplasty, described in literature, whose causes remain often undetermined.
Event or Problem Description
Revision surgery 6 years and 3 months after primary for stem mobilization and stress shielding.The surgeon revised successfully the stem, head and liner.The stem came out easily, the surgeon implanted an x-acta stem.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11580731
• Report Number: 3005180920-2021-00248
• Device Sequence Number: 11801603
• Product Code: JDI
• UDI-Device Identifier: 07630030802713
• UDI-Public: 07630030802713
• 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: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 02/28/2017
• Device Model Number: 01.12.31SN
• Device Catalogue Number: 01.12.31SN
• Device Lot Number: 115217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/29/2021
• 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: 75 YR
• Patient Weight: 70