MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H, CEMENTLESS, HA COATED STEM SIZE 0 STD, SHORT NECK; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.20SN
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 26 september 2017 the medical affairs director performed a clinical evaluation and commented as follows: hip revision surgery occurred 4 years after primary cementless total hip arthroplasty.Radiographic images provided show a radiographically loose stem, with no osseointegration taking place.The presence of two screws in the femoral bone and one in the ilium was not explained; they may indicate previous surgery that possibly made fixation more challenging.There is no history available; such a detachment could even suggest the possibility of a late infection, but there is no mention of this in the report.Aseptic loosening is a possible, literature described adverse event following cementless tha whose causes are often unknown.The reason of this failure cannot be determined.Batch review performed on 20 september 2017.(b)(4).On 13 october 2017 the r and d project manager performed a preliminary investigation based on the available pictures and commented as follows: the images showed a stem and a cup explanted, without any particular sign.The coating are almost totally absorbed in both the implants and the presence of blood is still evident on their surfaces.From the received photos it is not possible to determine the root cause of the event, but there are no reasons to connect the event to defects of the device.
Event or Problem Description
The patient had been complaining of pain.The requested the patient get an x-ray and determined the implant must be loose.Revision surgery was performed and the stem was removed as it was in fact loose.

• Brand Name: QUADRA-H, CEMENTLESS, HA COATED STEM SIZE 0 STD, SHORT NECK
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6947954
• Report Number: 3005180920-2017-00579
• Device Sequence Number: 11015708
• Product Code: LZO
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• 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: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: 06/30/2015
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 101455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/13/2017
• 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