MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 5 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.145
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 01 august 2017 and includes: the broach 00 has been used before the 0.The broach 0 has been well implanted.Trial reduction performed.Impaction performed with straight stem impactor.On 27 july 2017 the medical affairs director performed a clinical evaluation and commented as follows: the image was checked, there are no evident signs on the stem: the device appears to be just removed, with the blood still present on the surface and with the ha coating totally absorbed, showing a correct osseointegration.From the checked image it is not possible to determine the root cause of the event.On 28 july 2017 the r and d project manager performed a preliminary investigation based on the available image and commented as follows: 5,5 years after primary cementless tha in an elderly man, the stem was found loose.Radiographic signs of loosening and possibly of proximal osteolysis are visible.The stem found distal stability for a certain period of time, according to the radiographical signs, and then the progressive bone loss made it unstable and painful.The reason originating this situation cannot be determined.Progressive stem loosening is a possible complication following tha, described in literature.Batch review performed on 16 august 2017.(b)(4).
Event or Problem Description
The patient came in complaining of instability.The surgeon determined that the stem had loosened.The cause of the loosening is unknown.The surgeon revised the stem, head and liner.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 5 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6797195
• Report Number: 3005180920-2017-00444
• Device Sequence Number: 1039589
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 12/31/2014
• Device Catalogue Number: 01.18.145
• Device Lot Number: 092780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/16/2017
• 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: 85 YR