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

Model Number	01.12.32SN
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem, head, and liner 5 years and 6 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 april 2022.Lot 122653: 27 items manufactured and released on 14-sep-2012.Expiration date: 2017-aug-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2018.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14336935
• Report Number: 3005180920-2022-00349
• Device Sequence Number: 14752174
• Product Code: JDI
• UDI-Device Identifier: 07630030802720
• UDI-Public: 07630030802720
• 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: 2016
• Device Explanted Year: 2022
• 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): 05/09/2022

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: 08/31/2017
• Device Model Number: 01.12.32SN
• Device Catalogue Number: 01.12.32SN
• Device Lot Number: 122653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female