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

Catalog Number	01.12.21SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 september 2017.(b)(4).On 19 october 2017 the medical affairs director performed a clinical evaluation and commented as follows: stem revision at 5 years following cementless primary tha.The stem looks slightly undersized, the cup evidently proud from acetabulum.It is conceivable that the stem has not been able to find adequate primary stability and therefore effective bone ingrowth was never achieved.There is no indication that a faulty implant caused the adverse event.Additional information received on 19 october 2017 and includes: the tissue and cultures have been found to have no growth of any form of bacteria.The surgery was completed successfully on (b)(6) 2017.
Event or Problem Description
Patient had a loose femoral stem requiring revision.The stem was removed easily, the surgeon removed the bone from the shoulder of the implant and used the screw extractor to tap out the stem.There was little sign of o growth and he observed that the stem may have been undersized.

• Brand Name: QUADRA-H, CEMENTLESS, HA COATED STEM SIZE 1 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: 6961438
• Report Number: 3005180920-2017-00592
• Device Sequence Number: 13633085
• Product Code: LZO
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 01.12.21SN
• Device Lot Number: 103960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 10/19/2017
• 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