MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 7; CEMENTLESS STEM

Catalog Number	01.18.137
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 november 2019.Lot 124059: (b)(4) items manufactured and released on 17-dec-2012.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: partial hip revision surgery performed 3 years and 8 months after cementless total hip arthroplasty.No information concerning patient age, general health status and comorbidities is available.Radiographic image provided doesn't allow a proper clinical evaluation due to poor quality.On the basis of information received, no conclusion can be drawn.
Event or Problem Description
Revision surgery performed 3 years and 8 months after the primary due to a potted stem.The cause of the potted stem is unknown.The surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 7
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9488566
• Report Number: 3005180920-2019-01081
• Device Sequence Number: 16441413
• Product Code: LZO
• UDI-Device Identifier: 07630030804137
• UDI-Public: 07630030804137
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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: 10/31/2017
• Device Catalogue Number: 01.18.137
• Device Lot Number: 124059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/18/2019
• 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