MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14; HIP CEMENTED STEM

Model Number	01.12.043
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-feb-2020: lot 155701: (b)(4) items manufactured and released on 7 december 2015.Expiration date: 2020-11-23.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 clinical evaluation performed by medical affairs director hip revision performed 3,5 years after hybrid total hip arthroplasty in a heavy ((b)(6) kg) (b)(6) year old patient.No information concerning patient general heath status and comorbidities is available.Radiographic image provided shows the presence of signs of stress shielding.
Event or Problem Description
Hip revision after 3 years and 7 months from the primary due to stem loosening and infection suspicious.All implants were revised, no infection present.

• Brand Name: STEM: QUADRA-C CEMENTED, MIRROR POLISHING STD STEM SIZE 3 12/14
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 9848075
• Report Number: 3005180920-2020-00162
• Device Sequence Number: 13638965
• Product Code: LZO
• UDI-Device Identifier: 07630030802249
• UDI-Public: 07630030802249
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083558
• 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): 03/18/2020

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: 11/23/2020
• Device Model Number: 01.12.043
• Device Catalogue Number: 01.12.043
• Device Lot Number: 155701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/18/2020
• 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: 70 YR
• Patient Weight: 112