MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; CEMENTLESS STEM

Model Number	01.12.025
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021.Lot 120705: 60 items manufactured and released on (b)(6) 2012.Expiration date: 2017-05-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs manager: partial hip (stem, head and liner) revision performed 8,5 years after primary cementless total hip arthroplasty in 79 year old man.No information concerning patient general health status and the presence of comorbidities is available.The radiographic images provided don't allow a proper clinical evaluation due to poor quality.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.Preliminary investigation performed by r&d project manager: it is visible that all the ha on the stem body has been correctly absorbed to the bone.On the distal part of one side of the stem body a huge residual bone material is visible, maybe a high osteointegration in that area occurs and this residual bone is not present on the proximal body, usually cause of stress shielding.No signs of scratches are visible on the stem body.It is not possible to determine the final root cause of the reported loosening.
Event or Problem Description
Revision surgery performed 8 years and 5 months after the primary surgery due to stem mobilization.The liner, head and stem were revised.No sign of infection present, the stem was easily removed.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11492688
• Report Number: 3005180920-2021-00213
• Device Sequence Number: 5349246
• Product Code: LZO
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 05/31/2017
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 120705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/16/2021
• 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: 79 YR
• Patient Weight: 68