MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52; HIP UNCEMENTED SHELL

Model Number	02.07.0410SF
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 october 2021: lot 124078: (b)(4) items manufactured and released on 21-nov-2012.Expiration date: 2017-10-30 no anomalies found related to the problem.To date, all items of the same lot have been sold without a similar reported event since 2017.Additional device involved: quadra-h 01.12.20sn cementless, ha coated std stem # 0, short neck (k082792) batch review performed on 19 october 2021: lot 124078: (b)(4) items manufactured and released on 7-feb-2013.Expiration date: 2017-12-31 no anomalies found related to the problem.To date, all items of the same lot have been sold without a similar reported event since 2017.Clinical evaluation performed by medacta medical affairs director: 8 years after primary cementless tha the patient suffers from thigh pain and revision surgery is undertaken.Both stem and cup appear to be loose and are removed - easily.Only the pre-revision xray is available, therefore we cannot evaluate if the stem was perhaps slightly undersized and this may have contributed to a negative evolution.The bone on the index side does not look healthy, but we have no medical information on this aspect.The fact that while removing a loose cup a fracture occurred to the pelvic bone is rather unusual and in my opinion it contributes to the idea that osteomalacia of some sort may have intervened.Preliminary investigation performed by medacta r&d hip project manager on the shell picture: the photo shows the versafitcup extracted from the patient, with blood on its surface and fibrotic tissues present inside the macrostructure.No particular signs related to the event are visible, so from the received image and information, it is not possible to determine with certainty the root cause of the event.Preliminary investigation performed by medacta r&d hip project manager on the stem picture: looking at the image attached to the complaint it is visible the explanted stem covered with patient blood and assembled with femoral head.It seems that the ha coating on the stem body has been completely absorbed by patient bone, but it has to be confirmed during the visual inspection if the stem will be available.It is not possible to determine the root cause of reported stem loosening.
Event or Problem Description
At 8 years and 4 months after the primary, revision surgery was performed due to stem and cup mobilization.Since 2016 the patient had increasing heterotrophic ossification at the femur and radiolucent lines around the femoral stem neck and cup.During the surgery, a small acetabular fracture was noticed.The surgeon revised all implants.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12811729
• Report Number: 3005180920-2021-00879
• Device Sequence Number: 5484952
• Product Code: LZO
• UDI-Device Identifier: 07630030817663
• UDI-Public: 07630030817663
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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: 10/30/2017
• Device Model Number: 02.07.0410SF
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 124078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female