MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 0 HA COATED STD STEM #0; HIP CEMENTLESS STEM

Model Number	01.18.130
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 26 may 2020: lot 140743: (b)(4) items manufactured and released on 30-apr-2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event.Clinical evaluation: stem revision performed 3.5 years after primary cementless total hip arthroplasty in a (b)(6) year old man.In the radiographic image provided, the stem looks slightly undersized.The reason of this choice cannot be assessed on the basis of a single anteroposterior radiographic projection.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.
Event or Problem Description
Revision surgery performed 3 years and 6 months after the primary surgery due to stem mobilization.The surgeon revised the stem.

• Brand Name: STEM: AMISTEM H 0 HA COATED STD STEM #0
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10193999
• Report Number: 3005180920-2020-00356
• Device Sequence Number: 11506690
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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: 03/31/2019
• Device Model Number: 01.18.130
• Device Catalogue Number: 01.18.130
• Device Lot Number: 140743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/25/2020
• 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