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

Catalog Number	01.12.21SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 162966: (b)(4) items manufactured and released on 22 june 2016.Expiration date: 2021-05-29.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 clinical evaluation performed by medical affairs department: hip revision performed 2 years after cementless total hip arthroplasty in an overweight woman.Radiographic images provided show stem subsidence and shortened leg.According to the report the patient was complaining about pain since 6 months after surgery.No preoperative or immediate postoperative x-ray is available.Implant subsidence may be due to slightly undersized implant but also patient weight and developing bone quality alterations may facilitate the occurrence of this event.The reason of this event cannot be determined.Visual inspection performed by medacta hip r&d project manager: femoral stem: few scratches and opaque regions on the neck.Stem shows bone residuals.Acetabular shell with signs of removal; the pe liner shows removal signs as well.Nothing to highlight regarding femoral head.It is not possible to determine failure root cause.
Event or Problem Description
Revision surgery performed after about 2 years from the primary due to hip stem sinking.The surgery was completed successfully, all devices revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8743233
• Report Number: 3005180920-2019-00519
• Device Sequence Number: 2534871
• Product Code: JDI
• UDI-Device Identifier: 07630030802614
• UDI-Public: 07630030802614
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/28/2019

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: 05/29/2021
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 162966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/28/2019
• 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: 67 YR
• Patient Weight: 97