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

Catalog Number	01.12.022
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 august 2018; lot 173141: (b)(4) items manufactured and released on 26 september 2017 expiration date: 2022-09-17; 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.Other devices involved: reference 25060.2844 (k091967) bipolar head ø28x44; lot 175686: (b)(4) items manufactured and released on 15 december 2017.Expiration date:2022-11-30 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.Ceramic ball head (not marketed in us): no anomalies found.
Event or Problem Description
The patient complained hip pain 4 months after primary surgery.The surgeon suspected an infection and removed all the implants.New implants from competitors will be implanted.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793268
• Report Number: 3005180920-2018-00615
• Device Sequence Number: 19132057
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2018
• 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): 08/17/2018

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: 09/17/2022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 173141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• 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: 77 YR
• Patient Weight: 54