MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE4; CEMENTLESS HIP STEM

Catalog Number	01.18.144
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: hip revision surgery occurred 1 year and 8 months after total hip arthroplasty in a (b)(6) man.Radiographic image provided shows the presence of radiolucent lines around the stem and signs of stress shielding.Scattered alterations of bone quality and morphology are also visible in the proximal femur and pelvic bones.A new bone formation or bone detachment is visible lateral to the proximal femur, origin unknown, perhaps it could be more clear with an additional view.No information concerning comorbidities and patient general health is available.The reason of this event cannot be determined.Batch review performed on 11 february 2019: lot 170031: (b)(4) items manufactured and released on 22-jun-2017.Expiration date: 2022-06-07.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.
Event or Problem Description
On (b)(6) 2019 we were informed that a patient came in due to pain, 1 year and 8 months after primary surgery.After xray evaluation, lucent lines and ectopic bone growth were present.During revision procedure, performed on (b)(6) 2019, the stem was removed with little difficulty and there was no bony in-growth present.

• Brand Name: STEM: AMISTEM H 01.18.144 HA COATED LAT STEM SIZE4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8343141
• Report Number: 3005180920-2019-00059
• Device Sequence Number: 11271318
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 06/07/2022
• Device Catalogue Number: 01.18.144
• Device Lot Number: 170031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/15/2019
• 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: 72 YR