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

Model Number	01.12.023
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery following suspected liner wear and stem loosening 14 years and 4 months after primary.
Additional Manufacturer Narrative
Batch review performed on 12 may 2022.Lot 072771: (b)(4) items manufactured and released on 03-jan-2008.Expiration date: 2012-10-31.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 since 2013.Additional component involved: liner: cc e cc light 01.26.3244stt flat pe liner ø 32 / e (k103352) lot 072321: (b)(4) items manufactured and released on 20-nov-2007.Expiration date: 2012-09-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2013.Clinical evaluation performed by medical affairs department about 14 years after primary cementless tha the pe insert is worn and the stem loosened, with a visible presence of osteolysis that may have been induced as a reaction to wear debris.Gender, age, and activity of the patient were not reported.A standard pe inlay had been chosen at primary surgery.The presence of wear after 14 years in a standard pe inlay is rather normal and described in the literature; in this case, the insert was not completely worn out but the osteolytic reaction made the revision necessary.Visual inspection performed by r&d project managers from the inspection of the liner, signs of removal were present.The signs are related to the extraction of the liner, both the worn wall and the hole, caused by using the extraction screw.From the received parts it was difficult to evaluate the signs related to a potential wear and is not possible to determine with certainty the root cause of the event.Regarding the stem it is evaluated that whole ha coating on the stem body has been completely absorbed by patient bone as executed.Some signs and scratches with burns are present on the neck surface, probably due to revision surgery.A possible root cause of the stem loosening should be the osteolysis due to the pe liner wear as reported.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• 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: 14571958
• Report Number: 3005180920-2022-00417
• Device Sequence Number: 20103204
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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 Implanted Year: 2008
• 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): 05/31/2022

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: 10/31/2012
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 072771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2008
• 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: Unknown