MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 5; HIP CEMENTLESS STEM

Model Number	01.18.175
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 18 march 2020: lot 177124: (b)(4) items manufactured and released on 5-sep-2018.Expiration date: 2023-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d project manager: scratches and signs of femoral extraction, signs of osseointegration on proximal stem.It is not possible to establish a certain root cause.Clinical evaluation: delayed infection in cemented tka, 1 years and 8 months after primary operation.Infection is a known possible adverse event following every surgery, including tka's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery performed after 1 year and 5 months after the primary due to tight pain.The stem was fixed, osseointegration on the metaphysical part and no osseointegration on the distal part.Now the stem was also implanted with a varus inclination and the distal tip was pushing against the cortical wall of the femur.The stem was a std size 5 and was fairly easily removed with the extraction set.It was installed cemented quadra-c and put some cerclage wire on the great trochanter and below the lesser trochanter.

• Brand Name: AMISTEM-H PROXIMAL COATING STD STEM SIZE 5
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; CH 6874, CHE
• MDR Report Key: 10232765
• Report Number: 3005180920-2020-00383
• Device Sequence Number: 10905894
• Product Code: LZO
• UDI-Device Identifier: 07630030804403
• UDI-Public: 07630030804403
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2020

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: No Information
• Device Expiration Date: 01/25/2023
• Device Model Number: 01.18.175
• Device Catalogue Number: 01.18.175
• Device Lot Number: 177124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 07/06/2020
• 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: 81 YR
• Patient Weight: 80