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

Catalog Number	01.12.032
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 november 2018: lot 100778: (b)(4) items manufactured and released on 08-jun-2010.Expiration date: 2015-04-30.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.Visual inspection performed by r&d project manager: the stem appeared with ha coating totally absorbed and with some signs on the neck, most probably occurred during extraction.From the received piece it is not possible to determine the root cause of the event.
Event or Problem Description
About 7 years and 8 months after primary the surgeon revised the patient for stem loosening.The surgery was completed successfully.New implants: quadra h lat size 4 and mectacer 32mm ball head medium.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT 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: 8095225
• Report Number: 3005180920-2018-00917
• Device Sequence Number: 2640251
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 11/21/2018

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: 04/30/2015
• Device Catalogue Number: 01.12.032
• Device Lot Number: 100778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/21/2018
• 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 Weight: 70