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

Catalog Number	01.12.021
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on november 16, 2018; femoral component revision occurred 9 months after primary cementless total hip arthroplasty in a (b)(6) year-old obese woman.Femoral stem looks slightly undersized and reasons for this choice cannot be assessed not having a preoperative x-ray image: patient anatomy and bone morphological characteristics may be one cause.There is no reason to suspect a faulty device.Batch review performed on 27 november 2018; lot 161546: (b)(4) items manufactured and released on 01 june 2016.Expiration date: 2021-05-29; 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.
Event or Problem Description
Revision surgery due to stem loosening 10 months after the primary surgery.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8105807
• Report Number: 3005180920-2018-00951
• Device Sequence Number: 16673696
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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: 05/29/2021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 161546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/27/2018
• 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: 61 YR
• Patient Weight: 100