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 (b)(6) 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)(6) 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 osteointergration on proximal stem.It is not possible to establish a certain root cause.
Event or Problem Description
Revision surgery performed after 1 year and 5 months after the primary due to tight pain.The stem was fixed, osteointegration on the metaphysical part and no osteointegration 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: 9920158
• Report Number: 3005180920-2020-00215
• Device Sequence Number: 17003083
• 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): 04/03/2020

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: 04/03/2020
• 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