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

Catalog Number	01.12.032
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 november 2019.Lot 083625/t: 1 item manufactured and released on 19-may-2014.Expiration date: 2019-04-30.No anomalies found related to the problem.To date, 1 items of the same lot have been already sold.Clinical evaluation performed by medical affairs director: 5 years after primary cementless tha the femoral stem gets loose and needs revision.We have only one, poor-quality image: in this single projection the stem looks slightly undersized, but of course it's possible that in the perpendicular view the stability that allowed it to perform for 5 years is evident.Apart from this, we are unable to identify a potential cause for this loosening.
Event or Problem Description
Patient required revision due to thigh pain (stem loosening) almost 5 years after primary.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9401757
• Report Number: 3005180920-2019-01012
• Device Sequence Number: 2525128
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: 04/30/2019
• Device Catalogue Number: 01.12.032
• Device Lot Number: 083625/T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 12/03/2019
• 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: 67 YR
• Patient Weight: 70