MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6; CEMENTLESS STEM

Model Number	01.12.026
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 september 2020: lot 091218: (b)(4) items manufactured and released on 18-aug-2009.Expiration date: 2014-05-31.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.Additional items involved in the event, batch review performed on 28 september 2020: implants from ceramtec 38.39.7175.245.00 biolox forte ceramic ball head 12/14 ø 28 size s -3.5 (usa) (k073337) lot.092498 lot 092498: (b)(4) items manufactured and released on 20-oct-2009.Expiration date: 2014-12.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.Liner: versafitcup dm 01.26.2856m double mobility liner 28/dmh (k083116) lot.090257.Lot 090257: (b)(4) items manufactured and released on 31-may-2009.Expiration date: 2014-03-31.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.
Event or Problem Description
The patient came in, 11 years and 8 months after primary surgery, reporting pain and the cause of the pain is unknown.The surgeon revised the quadra h std size 6 stem, femoral head and dm liner.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10689733
• Report Number: 3005180920-2020-00714
• Device Sequence Number: 3899591
• Product Code: JDI
• UDI-Device Identifier: 07630030802072
• UDI-Public: 07630030802072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 05/31/2014
• Device Model Number: 01.12.026
• Device Catalogue Number: 01.12.026
• Device Lot Number: 091218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/16/2020
• 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