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

Catalog Number	01.18.142
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2017: (b)(4).Preliminary investigation (16nov2017) based on the picture received by the field performed by r and d product manager: the images were analyzed.It was not possible to analyze what it was declared about the coating, as the photos seem to show the stem with the coating totally absorbed; this apparently can suggest a good total osseointegration, but the presence of blood especially in the distal macrostructures suggests the possible hypothesis of a osseointegration mostly distal as declared by the surgeon.From the received information it is not possible to determine the root cause of the event.
Event or Problem Description
The patient has pain and the surgeon supposed a stem loosening 1 year and 6 months after primary.There was no osseointegration on the proximal part of the stem.On (b)(6) 2017 the stem was successfully replaced.
Additional Manufacturer Narrative
Analysis of x-ray performed by the medical affairs director: hip revision surgery occurred 1,5 years after primary cementless total hip arthroplasty.Radiographic images provided show slightly varus stem and reduced bone density in the trochanteric region.The reason of this positon may be due to particular patient anatomy.The stem looks also undersized, possibly for the same reasons.An undersized stem with a very pronounced offset is a mechanical challenge and may result in early aseptic loosening.Aseptic loosening is a possible, literature described adverse event after primary cementless tha.The reason of this event cannot be determined.

• Brand Name: AMISTEM H HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7040112
• Report Number: 3005180920-2017-00680
• Device Sequence Number: 2144178
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 11/24/2020
• Device Catalogue Number: 01.18.142
• Device Lot Number: 153982
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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: 51 YR
• Patient Weight: 72