MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H HA COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 02 february 2018: hip revision surgery occurred 4 years after primary implantation.Radiographic images provided show the presence of radiolucent lines in gruen zones 1 and 2.Aseptic loosening is a possible, literature described adverse event after primary tha and causes are often unknown.In this case, the reason of failure cannot be determined.Clinical evaluation performed on 13 february 2018 by r&d product manager: the stem was analyzed.Some signs were evident on the neck, due to the revision surgery to remove the stem.The ha coating was totally absorbed.There are no signs that indicate a failure of the device and from the received part it is not possible to determine the root cause of the event.Batch review performed on 13 february 2018, lot 120920: (b)(4) items manufactured and released on 30 may 2012.Expiration date: 2017-04-30 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
4 years and 2 months after primary the surgeon revised the patient for a stem loosening.The surgery was completed successfully.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7269586
• Report Number: 3005180920-2018-00038
• Device Sequence Number: 135195
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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: 04/30/2017
• Device Catalogue Number: 01.18.142
• Device Lot Number: 120920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/14/2018
• 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: 66 YR
• Patient Weight: 60