MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.18.145
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 jun 2019: lot 145429: (b)(4) items manufactured and released on 10-oct-2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event (complaint (b)(4)).Clinical evaluation performed by medical affairs manager: femoral component revision surgery occurred 4 years after cementless total hip arthroplasty in a heavy ((b)(6) kg), young ((b)(6) year old) man.Radiographic images provided show the presence of radiolucent lines around the stem and signs of stress shielding suggesting radiological mobilization.No information concerning patient general health and comorbidities is available.The reason of stem loosening cannot be determined.
Event or Problem Description
On (b)(6) 2019 we were alerted that a revision surgery has been performed on (b)(6) 2019, 4 years after primary, due to stem loosening.The stem was hyperfixed distally on the bone.

• Brand Name: STEM: AMISTEM H HA COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8670155
• Report Number: 3005180920-2019-00433
• Device Sequence Number: 16206834
• Product Code: LZO
• UDI-Device Identifier: 07630030804212
• UDI-Public: 07630030804212
• 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: 2015
• 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): 06/05/2019

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: 08/31/2019
• Device Catalogue Number: 01.18.145
• Device Lot Number: 145429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/05/2019
• 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: 52 YR
• Patient Weight: 114