MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM

Catalog Number	01.18.230
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 may 2019.Lot 124662: (b)(4) items manufactured and released on 09-jan-2013.Expiration date: 2017-11-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by r&d hip manager: preliminary investigation shows femoral neck deformation and scratches due to revision.Ha layer still intact on central and proximal part of the stem.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) occurred 4 years and 8 months after cementless total hip arthroplasty in a (b)(6) woman.Poor quality of images available doesn't allow a proper clinical investigation.However, bone alterations are visible around the stem, especially in the proximal regions, but it is not clear if they can be classified as radiolucencies or osteolysis.No conclusion can be drawn on the basis of available information.
Event or Problem Description
Revision surgery performed, 4 years and 8 months after primary surgery, due to femoral inflammation.The patient was suffering of pain.Stem and head were revised.
Additional Manufacturer Narrative
Device received on the (b)(6) 2019 and analyzed on the (b)(6) 2019.As discussed during visual inspection, there is no need to reopen the complaint as the root cause is the same.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 0
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8619671
• Report Number: 3005180920-2019-00380
• Device Sequence Number: 245201
• Product Code: LZO
• UDI-Device Identifier: 07630030804557
• UDI-Public: 07630030804557
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: 11/30/2017
• Device Catalogue Number: 01.18.230
• Device Lot Number: 124662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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: 57 YR
• Patient Weight: 65