MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO 01.26.3244STT FLAT PE LINER 32 / E; HIP LINER FLAT

Model Number	01.26.3244STT
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26.07.2021: lot 170105: (b)(4) items manufactured and released on 21-03-2017.Expiration date: 2022-03-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Visual inspection performed by r&d manager: from the received parts it was noticed some signs on the poly on the rim, probably occurred during the revision surgery; on the inner surface, also surface does not appear smooth, probably due to a third body presence, but it is not possible to determine with certainty.As the material is standard pe, a possible slight wear could be occurred; in order to have a better idea on that, quality control measurements on inner surface have been required.
Event or Problem Description
3 years and 11 months after the primary surgery, cup, head and liner were revised due to suspected liner wear.The surgeon implanted size 54 head, reinforcement cage with 3 screws and apricot 48 cup.
Additional Manufacturer Narrative
Medacta r&d hip project manager comments after device measurements: update of 22nd september 2021: measurements of the inner sphere were taken, but a comparison with the original piece was not possible.Respect to the specifications of the drawing, the dimension was slightly increased of about 0.4mm on the diameter.This increase of the dimension is small, and it's probably due to the presence of a third body in articulation, compatible with the scratches visible on the bearing surface.Clinical evaluation performed by medacta medical affairs director: 4 years after primary cementless thr, revision is required because, according to the report, abnormal wear of the pe insert has occurred.There is no radiograph available to show the position of the original hip, so we cannot comment on that.The possible osteolytic effect of the wear particles is not shown either, and it's not mentioned in the report.From the images received, it appears that the bearing surface of the cup is scratched, which is compatible with the presence of a third body in articulation, which could also explain the macroscopic wear after only 4 years, which clearly indicates that something abnormal has happened.Because of insufficient information, no final conclusion can be reached at this stage.

• Brand Name: VERSAFITCUP CC TRIO 01.26.3244STT FLAT PE LINER 32 / E
• Common Device Name: HIP LINER FLAT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12352941
• Report Number: 3005180920-2021-00663
• Device Sequence Number: 3887444
• Product Code: LZO
• UDI-Device Identifier: 07630030807589
• UDI-Public: 07630030807589
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup
• Report Date (Section B): 09/22/2021

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: 03/05/2022
• Device Model Number: 01.26.3244STT
• Device Catalogue Number: 01.26.3244STT
• Device Lot Number: 170105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: 80 YR
• Patient Weight: 83