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

Model Number	01.12.031
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 march 2021: lot 072273: (b)(4) items manufactured and released on 18-oct-2007.Expiration date: 2012-09-31.No anomalies found related to the problem.(b)(4) items has been re-sterilized as lot 072273/t and released on 07-nov-2013.Expiration date: 2018-09-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event since 1-1-2017.Clinical evaluation: stem revision performed 4 years and 8 months after primary cementless total hip arthroplasty in a (b)(6) year old man.In the radiographic image provided, signs of stress shielding are visible and the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation: looking at the images of the explanted stem it is visible that almost all ha coating on the stem body has been absorbed by patient bone as expected.There are only a few residual fragments of ha coating on the body.The root cause remains unknown.
Event or Problem Description
4 years and 8 months after primary, revision surgery for loose quadra h stem.The surgeon revised successfully the stem and head.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11568315
• Report Number: 3005180920-2021-00235
• Device Sequence Number: 11662413
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 01/31/2020
• Device Model Number: 01.12.031
• Device Catalogue Number: 01.12.031
• Device Lot Number: 072273/T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• 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: 71 YR
• Patient Weight: 80