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

Model Number 01.12.035

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 july 2020: lot 155406: (b)(4) items manufactured and released on 20-jan-2016.Expiration date: 2021-01-11.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: stem revision performed 2 years after primary double mobility cementless total hip arthroplasty in a (b)(6) year old patient.In the radiographic image provided the stem looks slightly undersized, but this may be due to the bone withdrawing from the stem: the postoperative radiograph was not supplied.A single anteroposterior radiographic projection does not allow, anyway, to evaluate possible undersizing.The fact that the stem had no ongrowth might also suggest that a silent infection process had taken place, preventing osteointegration to happen.The reason of this failure cannot be finally determined.Preliminary investigation: preliminary visual investigation highlight residual ha on the stem and bone residual.From the preliminary visual investigation it is not possible to determine the failure root cause.

Event Description

1 year and 10 months after primary surgery, revision surgery for suspected loosening of the stem.Stem, head and liner revised successfully.The stem come out easily, so the loosening is confirmed.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10389665
• MDR Text Key: 202537001
• Report Number: 3005180920-2020-00495
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/11/2021
• Device Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 155406
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 72