MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; ACETABULAR SHELL CC TRIO NO HOLES Ø56

Model Number	01.26.45.1156
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to stem and cup loosening, at about 10 years after primary.All components successfully revised.Primary surgery date unknown.
Additional Manufacturer Narrative
Batch review performed on 20 november 2024: lot 132587: (b)(4) items manufactured and released on 02-sep-2013.Expiration date: 2018-07-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Additional component involved: stem: amistem h 01.18.136 ha coated std stem size 6 (k093944) lot 132149: (b)(4) items manufactured and released on 05-aug-2013.Expiration date: 2018-06-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Visual inspection: stem: looking at the stem body an opaque white film is visible on approximately proximal half of the stem length.It seems this is ha residual.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, bone contact was achieved at the time of surgery.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.A potential unreported periprosthetic fracture may have contributed to the failure mechanism.Cup: from the received parts, no particular signs were noticed.The polyethylene liner appeared to be yellowed in the inner sphere, normally due to lipidic absorption, while the cup did show some fibrotic tissue present in the external dome, but no other particular signs were present.From the information and devices it is not possible to determine the route cause of the event.Clinical evaluation: a revision surgery was performed approximately 10 years afer the implantation of a tha, due to loosening of both the stem and the cup.The available x-ray image reveals a bone discontinuity in the subtrochanteric region, with a profile suggestive of pseudoarthrosis.Additionally, there are signs of bone alteration and rarefaction in the proximal femur, while the distal portion of the stem appears to be well-fitted in the femoral diaphysis.The pictures of the retrieved stem show resorption of the ha coating in the distal portion, which aligns also with the x-ray suggestions of osseointegration, whereas the ha coating is still present in the proximal portion.This suggests that an early fracture hindered the proximal part of the stem from achieving sufficient bone contact, and as a result, the ha coating was not exposed to the metabolic activity necessary for its resorption, which typically occurs within a few months post-implantation.The acetabular component also shows signs of bone remodeling without evidence of clear radiolucency from this specific x-ray projection.Additionally, the cup appears to be anteverted and protruding laterally, possibly due to insufficient reaming of the original acetabulum during the primary surgery.Conclusions: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Additional Manufacturer Narrative
In the initial emdr it was reported that the devices were not available and not analyzed due to a mistake.Error noted on 11 december 2024.Sections d9 and h3 updated.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL CC TRIO NO HOLES Ø56
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20843583
• Report Number: 3005180920-2024-01017
• Device Sequence Number: 17086460
• Product Code: LZO
• UDI-Device Identifier: 07630030807916
• UDI-Public: 07630030807916
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 12/11/2024

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: 07/31/2018
• Device Model Number: 01.26.45.1156
• Device Lot Number: 132587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2013
• 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 Sex: Unknown