MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4; HIP UNCEMENTED STEM

Catalog Number	01.12.004
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2019: lot 176740: (b)(4) items manufactured and released on 13-dec-2017.Expiration date: 2022-11-21.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.Clinical evaluation performed by medacta medical affairs director: hip revision surgery occurred 10 months after total hip arthroplasty.Radiographic image provided shows a mobilized stem.Alterations of bone morphology and density possibly due to systemic disease are visible but this cannot be confirmed as no information concerning patient general health is available.The stem position in the radiograph is significantly subsided and also the cup has no anteversion, but we cannot determine if this is the result of a mobilization as no postoperative xray is available.Massive ossification of the trochanteric region, of unknown origin.
Event or Problem Description
Revision surgery 10 months after the primary surgery due to extensive thigh pain.The x-ray examination showed mobilized stem.The stem has been removed and wagner style stem has been implanted with dac (antibiotic gel), antibiotic therapy.No infection present.

• Brand Name: STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8508150
• Report Number: 3005180920-2019-00267
• Device Sequence Number: 1019518
• Product Code: JDI
• UDI-Device Identifier: 07630030801853
• UDI-Public: 07630030801853
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 11/21/2022
• Device Catalogue Number: 01.12.004
• Device Lot Number: 176740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/12/2019
• 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: 62 YR
• Patient Weight: 90