MAUDE Adverse Event Report: MEDACTA SWITZERLAND STEM COLLARED HA COATED STD STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number 01.18.235

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Joint Disorder (2373)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2018: lot 166469: (b)(4) items manufactured and released on (b)(6) 2017.Expiration date: 2022-01-22.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on (b)(6) 2018: hip revision surgery occurred 9 months after primary cementless total hip arthroplasty in a (b)(6) kg patient.Aseptic loosening is a possible, literature described adverse event after cementless tha and causes are often unknown.In this case, the stem failed to find initial stability, for reasons that remain unknown.

Event Description

Revision surgery performed after 9 months from primary due to stem loosening.

Manufacturer Narrative

Visual inspection performed by r&d product manager on 28 march 2018 the collared stem appeared with a coating still present in the proximal area of the shaft, while some bone tissue were found in the macrostructures, especially in the distal part.A small groove were noticed on the neck, just under the taper.The ceramic ball head had some signs, probably occurred during the extraction.From the received parts it was not possible to determine the root cause of the event.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 5
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA SWITZERLAND; gewerbestrasse 3; frauenfeld, switzerland 8500 ; SZ 8500
• MDR Report Key: 7273175
• MDR Text Key: 100158280
• Report Number: 3005180920-2018-00045
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804601
• UDI-Public: 07630030804601
• Combination Product (y/n): N
• PMA/PMN Number: K121011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 01.18.235
• Device Lot Number: 166469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR