MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.12.035
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/18/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 june 2018.Lot 091202: (b)(4) items manufactured and released on 18 august 2009.Expiration date: 2014-05-31.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.Clinical evaluation performed by medical affairs director on 15 june 2018.Hip revision surgery occurred 8 years after primary cementless total hip arthroplasty in a (b)(6) man.Head and cup belong to a different company and no information is available.The quality of the pictures is very poor, but it seems possible that a large head metal-on-metal combination was used 8 years ago and a massive debris production could be an explanation for the radiopaque finding proximo-lateral in the femur and for the late loosening.The stem looks slightly undersized but it served well for many years, so that's unlikely to be a potential cause.
Event or Problem Description
The patient came in complaining of pain 8 years and 4 months after primary.Intraoperatively the surgeon determined that the stem was loose.The surgeon revised the medacta stem, along with the other company's cup, head and liner.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7624916
• Report Number: 3005180920-2018-00443
• Device Sequence Number: 2067318
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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: 05/31/2014
• Device Catalogue Number: 01.12.035
• Device Lot Number: 091202
• 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: 05/23/2018
• Initial Report FDA Received Date: 06/21/2018
• 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: 55 YR