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

Model Number	01.12.021
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 april 2021: lot 103104: (b)(4) items manufactured and released on 03-jan-2011.Expiration date: 2015-11-30 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 medacta clinical affairs director: femoral component (stem, head and liner) revision performed 9.5 years after primary cementless total hip arthroplasty in a (b)(6) year old woman.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, the stem looks loosened.It must also have migrated from the original position, but this cannot be determined because no radiographic history is available.There is no mention of a traumatic event, but we cannot exclude it happened.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.
Event or Problem Description
Revision surgery performed due to stem mobilization 9 years and 5 months after the primary.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11831977
• Report Number: 3005180920-2021-00388
• Device Sequence Number: 11839268
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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: 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): 05/17/2021

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: 11/30/2015
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 103104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• 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: 65 YR
• Patient Weight: 70