MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; UNCEMENTED HIP STEM

Model Number	01.12.024
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12.03.2021: lot 052090: (b)(4) items manufactured and released on 31-mar-2006.Expiration date: 2011-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by medacta r&d project manager: looking at the image attached to the complaint is visible that the whole ha coating on the stem body has been absorbed by patient bone as expected.No particular signs or damages are present on the explanted stem.It is not possible to define a root cause of the reported loosening.Clinical evaluation performed by medacta medical affairs director: femoral component revision performed about 14,5 years after primary cementless total hip arthroplasty in a (b)(6) year old man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, signs of osteolysis and stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.Of course the probability that a total hips involved in phenomena of stress shielding and osteolysis is bound to increase with time and activity, as specified in the instructions for use.The exact reason of this event cannot be determined.
Event or Problem Description
Loosening of a quadra-h (4 std) stem after 14 years and 7 months after the primary surgery.The surgeon revised the stem, head and inlay.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11593997
• Report Number: 3005180920-2021-00251
• Device Sequence Number: 3474165
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2006
• Device Explanted Year: 2021
• 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): 03/31/2021

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: 02/28/2011
• Device Model Number: 01.12.024
• Device Catalogue Number: 01.12.024
• Device Lot Number: 052090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/31/2021
• 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: 58 YR