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

Catalog Number	01.12.31SN
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 30 june 2017 the medical affairs director performed a clinical evaluation and commented as follows: total hip revision surgery occurred 8 years after primary cementless tha.Radiographic image provided shows the presence of areas of osteolysis around the femoral stem probably due to the normal reaction to polyethylene debris.The production of polyethylene debris as a result of wear is a possible, literature described finding at mid-long term after hip replacement with polyethylene as a bearing surface.Batch review performed on 13 july 2017.(b)(4).
Event or Problem Description
The patient came in complaining of pain.The surgeon determined that the stem was loose.The surgeon revised all medacta components.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 1 LAT, 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: 6714003
• Report Number: 3005180920-2017-00375
• Device Sequence Number: 13769954
• Product Code: JDI
• UDI-Device Identifier: 07630030802713
• UDI-Public: 07630030802713
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

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: 02/28/2014
• Device Catalogue Number: 01.12.31SN
• Device Lot Number: 090171
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2017
• Initial Report FDA Received Date: 07/14/2017
• 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