MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.035
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: hip revision surgery occurred 5 years after primary cementless total hip arthroplasty.The patient was complaining about pain.The single radiographic image provided shows the presence of radiolucent lines in gruen zones 1 and 7 that are suggestive of implant aseptic mobilization.The stem looks slightly undersized and in varus position.This could be due to a particular patient anatomy that cannot be assessed on the basis of the single antero-posterior x-ray available.Aseptic loosening is a possible, literature described adverse event after primary cementless tha and causes are often unknown.The reason of this failure cannot be determined.Batch review performed on (b)(6) 2017.Lot 091202/t: (b)(4) item manufactured and released on 02 february 2011.Expiration date: 2015-12-31.No anomalies found related to the problem.
Event or Problem Description
The patient complained of pain.The surgeon suspected it was loose.Intra-operatively it was concluded the stem was loose and it was removed and replaced.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6847620
• Report Number: 3005180920-2017-00498
• Device Sequence Number: 11143681
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: 12/31/2015
• Device Catalogue Number: 01.12.035
• Device Lot Number: 091202/T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• 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