MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE2; CEMENTLESS HIP STEM

Catalog Number	01.18.142
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 october 2018.Lot 110851: (b)(4) items manufactured and released on 22 april 2011.Expiration date: 2016-03-31.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.Clinical evaluation performed on oct 8, 2018 by medical affairs manager: hip revision surgery occurred 7 years after primary cementless total hip arthroplasty in a (b)(6) year old patient.Radiographic images provided show the presence of radiolucent lines around the stem profile suggesting implant mobilization.Aseptic loosening is a possible mid-long term adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.Preliminary investigation performed by r&d project manager: from the received images the stem showed a surface with the coating totally absorbed; we can assume that the initial contact with bone and press-fit was achieved but a mid term adverse event could occurred.A possible cause, in accordance with the medical direction, can be aseptic loosening but the causes are often unknown.
Event or Problem Description
On (b)(4) 2018 we were informed that the surgeon was going to perform a revision surgery 7 years after primary due to insufficient osseointegration in the proximal part of the stem.On (b)(6) 2018 the revision was performed: the stem, head and liner were revised.Surgery completed successfully.The patient had the same issue also on the opposite leg.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7973278
• Report Number: 3005180920-2018-00789
• Device Sequence Number: 10813531
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 03/31/2016
• Device Catalogue Number: 01.18.142
• Device Lot Number: 110851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/17/2018
• 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: 68 YR