MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; HIP CEMENTLESS STEM

Model Number	01.12.021
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery following stem loosening, no infection has been detected.The device was implanted in 2013, the exact primary surgery date is unknown.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 124026: (b)(6) items manufactured and released on (b)(6) 2012.Expiration date: 2017-11-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Additional Manufacturer Narrative
On the 05th of july 2022 we have received the stem involved in the event and the liner and the head even if are associated component.Visual inspectiion performed by r&d project manager: during the visual inspection it has been noticed that part of the proximal aspect of the stem is covered with ha coating meaning that the stem was not completely osseointegrated with the patient bone.Some signs and scratches are present on the neck surface of the stem and on the pe liner probably due to revision surgery.It is not possible to determine the root cause of uncorrect stem osseointegration.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Common Device Name: HIP CEMENTLESS STEM
• 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: 14250187
• Report Number: 3005180920-2022-00314
• Device Sequence Number: 4159185
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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: 11/30/2017
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 124026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2012
• 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 Age: 51 YR
• Patient Sex: Male