MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P LAT STEM SIZE 2; HIP CEMENTLESS STEM

Catalog Number	01.12.142
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-apr-2024: lot 2117667: (b)(4) items manufactured and released on 26-apr-2022.Expiration date: 2027-04-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta medical affairs manager: revision 1 year and 5 months after primary tha, due to stem subsidence.In the radiographic image provided, the stem appears slightly undersized and this may have contributed to cause the subsidence.There is no reason to suspect a mafunctioning device.
Event or Problem Description
At about 1 year and 5 months after primary, the patient came in reporting pain and stem subsidence.The surgeon revised successfully all components.

• Brand Name: STEM: QUADRA-P LAT STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19238298
• Report Number: 3005180920-2024-00254
• Device Sequence Number: 7997003
• Product Code: LZO
• UDI-Device Identifier: 07630040720540
• UDI-Public: 07630040720540
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 05/03/2024

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 Catalogue Number: 01.12.142
• Device Lot Number: 2117667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Race: White