MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STEM SIZE 3 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.243
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 17 july 2017 the medical affairs director performed a clinical evaluation and commented as follows: femoral stem loosening in cementless tha less than 1 year after primary.No contact or osseointegration is visible from the pre-revision x-rays.According to report, the patient's bone quality was deemed poor, a known and reported partial contraindication to a cementless implant.Signs are radiographically visible that may be consequent to a fracture fixation implant, this may have contributed to poor bone quality, in spite of young age of the patient.We see no reason to ascribe this failure to a faulty device.Batch review performed on 19july 2017.(b)(4).
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the stem was loose.The loosening was due to poor bone quality.The surgeon revised the stem, head and liner.The surgery was completed successfully.Explants are not available.

• Brand Name: AMISTEM COLLARED HA COATED STEM SIZE 3 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6727727
• Report Number: 3005180920-2017-00392
• Device Sequence Number: 16486848
• Product Code: LZO
• UDI-Device Identifier: 07630030804687
• UDI-Public: 07630030804687
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: 12/16/2020
• Device Catalogue Number: 01.18.243
• Device Lot Number: 155255
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/20/2017
• 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
• Patient Age: 53 YR