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

Model Number	01.12.021
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2021: lot 156210: (b)(4) items manufactured and released on 15-june-2016.Expiration date: 2021-01-03.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 1-1-2017.
Event or Problem Description
The surgeon will revise the patient hip on (b)(6) 2021.The patient has hip pain and a stem loosening is suspected.For the revision planned 4 years and 8 months after primary the surgeon plans to revise all the products.
Event or Problem Description
Revision surgery was performed 4 years and 8 months after primary for stem loosening.All implants were revised successfully.The acetabular components swap was a surgeon choice, there were no acetabular problems, but the surgeon revised them to reduce the risk of potential infection due to the surgery.
Additional Manufacturer Narrative
On (b)(6) we were informed that the revision surgery was performed and completed successfully.Clinical evaluation performed by medical affairs director: hip revision surgery performed 4 years and 8 months after primary cementless total hip arthroplasty in a 64 year old man.In the radiographic image provided the stem looks slightly varus and, in the pre-revision situation, undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by r&d project manager: the implant is not clearly visible in the photo attached to the complaint due the fact that it is inside a plastic box.What visible is that the ha coating on the stem body is completely absorbed by patient bone as expected.It is not possible to see if some scratches are present or not.It is not possible to determine the root cause of the reported patient pain.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11938602
• Report Number: 3005180920-2021-00468
• Device Sequence Number: 1085633
• 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 Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 07/07/2021

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: 01/03/2021
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 156210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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
• Patient Age: 65 YR
• Patient Weight: 74