MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM

Model Number	01.18.146
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 april 2021: lot 100550: (b)(4) items manufactured and released on 16-apr-2010.Expiration date: 2015-03-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event since (b)(6) 2017.Clinical evaluation performed by medical affairs manager: femoral component (stem and head) revision performed 9 years and 8 months after primary cementless total hip arthroplasty in (b)(6) year old man.No information concerning patient general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.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 is clearly visbile that the ha coating on the stem body is almost completely absorbed by the patient bone.Only few residuals of ha coating are present in such part of the stem body, one square shaped residual on the tip part.Some screatches are present in the zone on neck and taper probably due to the revision surgery.It is not possible to determine the root cause of the reported loosening.
Event or Problem Description
Revision surgery 9 years and 8 months after primary, for aseptic loosening of the stem.The surgeon revised successfully the stem and head.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11812570
• Report Number: 3005180920-2021-00377
• Device Sequence Number: 3910658
• Product Code: LZO
• UDI-Device Identifier: 07630030804229
• UDI-Public: 07630030804229
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• 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): 05/12/2021

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: 03/31/2015
• Device Model Number: 01.18.146
• Device Catalogue Number: 01.18.146
• Device Lot Number: 100550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/12/2021
• 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: 88 YR