MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 4 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.144
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 november 2017.Lot 120527: (b)(4) items manufactured and released on 04 may 2012.Expiration date: 2017-03-31.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
Five years after primary a femoral bone reabsorption due to stress shielding was detected in the patient.The surgeon revised successfully the hip swapping the stem and the ceramic head.
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director made the following analysis.Femoral revision in primary cementless tha 4 years after index operation.The images show a radiographically loose stem, with failure of osteointegration all along.This is also confirmed by the explanted device.The reason why the host bone failed to osteintegrate is not known; sometimes similar cases have been reported to be latent (or silent) infections, but there are not sufficient elements to draw this conclusion.This hypothesis is not confirmed by scintigraphy (but silent infections rarely are).According to report, the cause is stress shielding, but there is no evidence of a distally-fixed stem.This does not exclude the possibility that a mechanical cause be tat the origin of the problem, but makes it rather unlikely.Unfortunately, we are unable to draw a final conclusion based on the available information.On the (b)(6) the r&d project manager analysed the images of the explants: from the images no conclusions can be drawn.On the stem some scratches can be noted.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 4 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7037228
• Report Number: 3005180920-2017-00665
• Device Sequence Number: 1275198
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• 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,Followup
• Report Date (Section B): 12/15/2017

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: 03/31/2017
• Device Catalogue Number: 01.18.144
• Device Lot Number: 120527
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: 69 YR