MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED, HA COATED STEM SIZE 1 STD; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.231
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 08 september 2017 the medical affairs performed a clinical evaluation and commented as follows: partial hip revision surgery (stem, head and liner) occurred 2 years after primary cementless tha.No patients details are available.In the single x-ray provided small radiolucent lines are visible in gruen zone 1 and the stem looks slightly in varus position.This choice could be due to a particular patient anatomy that cannot be assessed having a single radiographic projection.From the ap view it also appears significantly undersized, but this hypothesis should be evaluated looking at both projections.Aseptic loosening is a possible literature described adverse event after primary tha and causes are often unknown.On the basis of the information received by the manufacturer, it is not possible to determine the reason of this failure.Batch review performed on 11 september 2017.Lot 147175: (b)(4) items manufactured and released on 21 january 2015.Expiration date: 2019-12-31.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
The patient came in complaining of instability.The surgeon determined the stem was loose.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED, HA COATED STEM SIZE 1 STD
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6860921
• Report Number: 3005180920-2017-00513
• Device Sequence Number: 19007686
• Product Code: LZO
• UDI-Device Identifier: 07630030804564
• UDI-Public: 07630030804564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/13/2017

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: 12/31/2019
• Device Catalogue Number: 01.18.231
• Device Lot Number: 147175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/13/2017
• 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