MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 4; HIP STEM CEMENTLESS

Model Number	01.18.134
Medical Device Problem Codes	Osseointegration Problem (3003); Positioning Problem (3009)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 years and 9 months after the primary surgery, the patient was revised and the stem was found loose while cup was malseated.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical evaluation revision almost 5 years after cementless tha in a 71 year old patient.According to report, the revision was done due to stem loosening and cup malposition.The radiographic image pre-revision shows the presence of radiolucent line in gruenzones 1 and 7 while it is not possible to determine if the position of the cup evolved into such position.In the pre-revision xray, which is available only in one projection, the cortical walls are not in close contact with the stem.Again, we cannot determine if this resulted from evolution of the bone during the 5 years of operational life of the implant or if it was intentionally implanted relying on cancellous support.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation performed by r&d project manager.Looking at the image it is visible the stem covered with patient blood.The ha on the stem body seems to be completely absorbed by patient bone as expected.Some signs and scratches are present on the neck part due to revision surgery.It is not possible to determine the root cause of reported stem loosening.Batch review performed on 25-jul-2022: lot 133064: (b)(4) items manufactured and released on 09-oct-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other component involved: cup: versafitcup 01.26.45.1154 acetabular shell cc trio no-hole ø 54 lot 170950: (b)(4) items manufactured and released on 30-jun-2017.Expiration date: 2022-06-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15259348
• Report Number: 3005180920-2022-00625
• Device Sequence Number: 17810544
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 08/31/2018
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 133064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male