MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 6; CEMENTLESS HIP STEM

Model Number	01.18.136
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2020: lot 176509: (b)(4) items manufactured and released on 21-feb-2018.Expiration date: 2023-02-09.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 (considering infection and mobilization).
Event or Problem Description
Revision surgery for hip stem loosening, about 1 year and 8 months after primary surgery.The surgery was completed successfully.A bacteriological sampling was made at the femoral level and it revealed the presence of staphylococcus, which could indicate that the hip revision was due to a septic loosening.Medacta (b)(4) is recovering more information about this.
Additional Manufacturer Narrative
Visual inspection: visual inspection performed on (b)(6) 2020.From the received part it was possible to note the presence of the coating on the stem, except the distal part.The root cause related to this event is, as stated by the hospital, related to the detected infection.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10801095
• Report Number: 3005180920-2020-00784
• Device Sequence Number: 16882361
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 02/09/2023
• Device Model Number: 01.18.136
• Device Catalogue Number: 01.18.136
• Device Lot Number: 176509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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