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

Model Number	01.12.032
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 december 2019: lot 152982: (b)(4) items manufactured and released on 26-oct-2015.Expiration date: 2020-10-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical affairs manager: hip revision surgery performed 1 year after cementless total hip arthroplasy in a 69 year old woman.No information concerning patient health status, bone quality or presence of comorbidities is available.In the radiographic images provided, radiolucent lines around the stem and signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.In this case external conditions such as early subclinical traumatic events or systemic conditions may have affected stem osseointegration but this cannot be confirmed on the basis of available information.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed almost 1 year and 2 months after primary following stem loosening.More details will follow once the surgery will be completed.
Event or Problem Description
Revision surgery performed almost 1 year and 2 months after primary following stem loosening.Stem, head and liner were revised.The surgery was completed successfully.
Additional Manufacturer Narrative
Event description has been updated.Stem received on 04.02.2020: visual inspection performed by medacta r&d deprtement : the visual inspection shows intact ha layer from cetral to proximal part of the femoral stem.There are present signs of extraction on head, liner, and neck.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9600143
• Report Number: 3005180920-2019-01153
• Device Sequence Number: 14078656
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 10/07/2020
• Device Model Number: 01.12.032
• Device Catalogue Number: 01.12.032
• Device Lot Number: 152982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/27/2020
• 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: 69 YR
• Patient Weight: 70