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

Catalog Number	01.18.400
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2020 lot 1904131: 45 items manufactured and released on (b)(6) 2019.Expiration date: 2024-07-23.No anomalies found related to the problem.To date, 15 items of the same lot have been already sold without any other similar reported event.Clinical evaluation shortly after primary cementless tha a wound infection occurs.When this is healed, the hip is however painful and removed; no physiological fixation had been achieved.Analysis revealed no further germs on the components.No final conclusion as to the cause of this adverse event can be drawn.The presence of an early infection should however not be forgotten, though its role in the subsequent mobilization cannot be positively determined.
Event or Problem Description
The patient was primarly operated on (b)(6) 2019.After this first surgery she had an infect of the wound which healed.However since the surgery she always had pain and difficulties in walking.Therefore 9 months after primary the hip was revised and everything was removed.The stem was loose.Nothing new was implanted, since also bacteriological tests were done to see if there is a possible infect.Nothing has been identified by bacteriological tests and the staphylococcus on the stem is likely due to some contamination, so the loosening is not due to an infection.On the (b)(6) 2020 a versacem 56 with a 28xl head (cocr) and a 2std p amistem were implanted.The operation went well.

• Brand Name: STEM: AMISTEM P STD STEM SIZE 0
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10593613
• Report Number: 3005180920-2020-00655
• Device Sequence Number: 11745905
• Product Code: LZO
• UDI-Device Identifier: 07630040719995
• UDI-Public: 07630040719995
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 07/23/2024
• Device Catalogue Number: 01.18.400
• Device Lot Number: 1904131
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/28/2020
• 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: 79 YR