MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; HIP CEMENTLESS STEM

Model Number	01.12.23SN
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2020: lot 162968: (b)(4) items manufactured and released on 06-jul-2016.Expiration date: 2021-06-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 lot.162360 (k072857).Batch review performed on 24 july 2020: lot 162360: (b)(4) items manufactured and released on 26-jul-2016.Expiration date: 2021-06-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Ball heads: bipolar head 25060.2845 bipolar head ø28x45 lot.161084 (k091967).Batch review performed on 24 july 2020: lot 161084: (b)(4) items manufactured and released on 24-may-2016.Expiration date: 2021-05-03.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.
Event or Problem Description
The patient came in reporting pain and the cause of the pain is unknown.The surgeon revised the bipolar hip components to total hip components 3 years and 8 months after primary.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10389669
• Report Number: 3005180920-2020-00509
• Device Sequence Number: 2259356
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: No Information
• Device Expiration Date: 06/22/2021
• Device Model Number: 01.12.23SN
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 162968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/11/2020
• 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