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

Lot Number	102759
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18-dec-2019: lot 102759: (b)(4) items manufactured and released on 01-oct-2010.Expiration date: 31/08/2015.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medial affairs director: partial hip revision surgery (stem and head) performed 9 years after cementless total hip arthroplasty in a (b)(4) heavy patient ((b)(4)).According to report, the stem was fixed only distally, and this may be due to the progressive rarefaction of the proximal bone in the elderly patient, although of course this does not happen all the times.Poor quality of the images provided doesn't allow a proper clinical evaluation.
Event or Problem Description
Revision surgery performed 9 years after primary due to stem potting, hyper fixation on the distal stem part.

• Brand Name: STEM: AMISTEM H COATED LAT STEM SIZE 6
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9574059
• Report Number: 3005180920-2019-01123
• Device Sequence Number: 19640900
• Product Code: LZO
• UDI-Device Identifier: 07630030804229
• UDI-Public: 07630030804229
• 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: 2010
• 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): 01/10/2020

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: Health Professional
• Device Expiration Date: 08/31/2015
• Device Lot Number: 102759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/10/2020
• 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
• Patient Age: 82 YR
• Patient Weight: 103