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

Catalog Number 01.12.025

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05-nov-2019.Lot 153852: 17 items manufactured and released on 29-oct-2015.Expiration date: 2020-10-12.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation: revision surgery performed 3 years and 8 months after cementless total hip arthroplasty in a (b)(6) woman.The patient was complaining about pain.Radiological image provided shows the presence of radiolucent lines in gruen zone 1 and 7 and signs of stress shielding.Heterotopic ossification is visible near the grater trochanter.On the basis of information provided, it is not possible to determine the origin of pain.

Event Description

Revision surgery performed 3 years and 8 months after primary surgery due to stem loosening.

Event Description

Explants received on the 4 decemeber and analyzed on the 6th december 2019.

Manufacturer Narrative

Explants received on the 4 decemeber and analyzed on the 6th december 2019.Visual inspection performed by medacta r&d hip project manager: signs of bone growth on the proximal and distal stem.Signs of bone growth on the cup equatorial and polar regions.Sing of scratches on the stem neck and head probably due to the revision procedure.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9362907
• MDR Text Key: 168226247
• Report Number: 3005180920-2019-00977
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (y/n): N
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2020
• Device Catalogue Number: 01.12.025
• Device Lot Number: 153852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 75