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
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Revision surgery performed 3 years and 8 months after primary surgery due to stem loosening.
Event or Problem Description
Explants received on the 4 decemeber and analyzed on the 6th december 2019.
Additional 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
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9362907
• Report Number: 3005180920-2019-00977
• Device Sequence Number: 3231296
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 63 YR
• Patient Weight: 75