MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2; CEMENTLESS STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2020: lot 1903222: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-07.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.Additional item involved in the event, batch review performed on 05 june 2020: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.1810793.Lot 1810793: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-18.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.
Event or Problem Description
The patient came in reporting a leg length discrepancy.Primary case was amis and there were no trouble during stem implantation.The surgeon checked the leg length using a overlay on the c-arm image of a scout film.However, sometimes he had to adjust the bed height and the images are off.The stem set proud (higher than it should have been in relation to the femur) after the primary surgery.The surgeon revised the stem and head 3 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• MDR Report Key: 10193922
• Report Number: 3005180920-2020-00359
• Device Sequence Number: 11403267
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: 07/07/2024
• Device Catalogue Number: 01.18.402
• Device Lot Number: 1903222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/25/2020
• 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: 35 YR