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

Catalog Number	01.12.031
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 july 2018: lot 081586: (b)(4) items manufactured and released on 28 february 2008.Expiration date: 30.06.2013 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 28 june 2018 stem revision occurred 6 years after primary cementless total hip arthroplasty in a young man ((b)(6) at time of primary surgery).In the radiographic image provided, signs of stress shielding are visible and the stem looks slightly undersized.The reason of this choice may be due to particular patient anatomy or bone morphology but this cannot be assessed on the basis of the single postoperative anteroposterior radiographic projection received.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 6 years after primary due to stem loosened over time: the size 1 lat quadra-h was revised with a size 3 quadra-h lat.This revision was not due to any issues with the implant itself.The outcome of the case was positive.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT 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: 7685639
• Report Number: 3005180920-2018-00504
• Device Sequence Number: 16472703
• 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: 2012
• 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): 07/13/2018

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: 06/30/2013
• Device Catalogue Number: 01.12.031
• Device Lot Number: 081586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/13/2018
• 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
• Patient Weight: 85