MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS STEM SIZE 5; HIP CEMENTLESS STEM

Catalog Number	01.12.035
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department partial hip revision surgery (stem and head) occurred 4 years and 3 months after cementless total hip arthroplasty in a (b)(6) year old heavy ((b)(6) kg) man.Radiographic image provided shows the presence of signs of stress shielding suggesting distal fixation of the stem.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.Batch review performed on 12 april 2019: lot 147653: (b)(4) items manufactured and released on 11-feb-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold, without any other similar event reported.
Event or Problem Description
On march 18 we were informed about a revision surgery planned on march 19.Revision performed 4 years and 3 months from the primary due to left side stem loosening.The reason of the mobilization is unknown.The revision surgery completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the implant shows ha layer almost fully absorbed, metal transfer scratch on the femoral head.It is not possible to determine a failure root cause.
Additional Manufacturer Narrative
On may 03, 2019 we were informed that the primary surgery date reported in the initial report was wrong (01-gen-2015) and the correct one was 07 aug 2015.So, the revision was performed 3 years and 7 months after the primary case.

• Brand Name: STEM: QUADRA-H CEMENTLESS STEM SIZE 5
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8522865
• Report Number: 3005180920-2019-00279
• Device Sequence Number: 11430917
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2019

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: 12/31/2019
• Device Catalogue Number: 01.12.035
• Device Lot Number: 147653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/17/2019; 05/29/2019
• 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: 56 YR
• Patient Weight: 106