MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.182
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 august 2019: lot 161308: (b)(4) items manufactured and released on 29-apr-2016.Expiration date: 2021-04-19.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.Clinical evaluation performed by medical affairs director: stem revision performed 2 years and 9 months after primary cementless total hip arthroplasty in a (b)(6) year old man with extremely narrow femoral canals.In the radiographic image provided, radiolucent lines around the stem and signs of stress shielding are visible.The stem could only find mechanical stability in its distal part.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.Visual inspection performed by r&d project manager: femoral stem shows residual ha on the proximal part.Signs of revision and extraction on the neck.Signs of mild fretting on the trunnion taper.This is also highlighted in the taer cavity of the head.
Event or Problem Description
We were informed on (b)(4) 2019 that a revision surgery, following a loose stem, would have been performed on (b)(6) 2019 (2 years and 9 months after primary surgery).The cause of the loosening isn't known.Since the stem was changed, the surgeon also changed the head and the inlay.

• Brand Name: STEM: AMISTEM-H PROX. COAT AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8979018
• Report Number: 3005180920-2019-00755
• Device Sequence Number: 19655235
• Product Code: LZO
• UDI-Device Identifier: 07630030804472
• UDI-Public: 07630030804472
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/10/2019

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: 04/19/2021
• Device Catalogue Number: 01.18.182
• Device Lot Number: 161308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/10/2019
• 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: 63 YR