MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E; HIP HC LINER

Catalog Number	01.26.3244HCT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-jul-2024 lot 136292: (b)(6) items manufactured and released on 12-feb-2014.Expiration date: 2018-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.
Event or Problem Description
At about 10 years and 1 month after primary, the patient has been revised because of cyst resorption probably caused by pe liner wear.The liner has been successfully revised.
Additional Manufacturer Narrative
Visual inspection performed on (b)(6) 2024.The liner appeared damaged due to the presence of scratches, grooves and extraction screw hole drilled during revision surgery to extract the liner from the shell.A yellowed color was present in the entire inner surface and in the central band in the outer cone.From the visual analysis, there were no particular or evident signs other than a slight eccentric deformation of the inner socket; for these reasons, a qc analysis from in-depth scans will follow to try to reconstruct the current geometry and compare it to the design specifications.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager and updated after the analysis performed by the cq: the liner appeared damaged due to the presence of scratches, grooves and extraction screw hole drilled during revision surgery to extract the liner from the shell.A yellowed color was present in the entire inner surface and in the central band in the outer cone.From the visual analysis, there were no particular or evident signs other than a slight eccentric deformation of the inner socket; for these reasons, a qc analysis from in-depth scans will follow to try to reconstruct the current geometry and compare it to the design specifications.Clinical evaluation performed by medical affairs director: 10 years after primary cementless tha, a resorption cyst is identified at follow up and the surgeon decides to proceed with a substitution of the pe insert.The hypothesis made by the surgeon is that the cyst had been originated by pe wear, which is of course possible.The decision to proceed with revision before the clinical condition of the patient could deteriorate is clearly a medical decision: we understand that at this time the surgery was very short and little traumatic, although someone could consider it to be too early.The wear of pe is hardly visible on the low-quality images reported.
Additional Manufacturer Narrative
We have noticed on (b)(6) 2024 that the visual inspection reported in the follow-up 2 was not the updated one after the quality control analysis.Visual inspection performed by r&d project manager that update the previous one: the liner appeared damaged due to the presence of scratches, grooves and extraction screw hole drilled during revision surgery to extract the liner from the shell.A yellowed color was present in the entire inner surface and in the central band in the outer cone.From the visual analysis, there were no particular or evident signs other than a slight eccentric deformation of the inner socket; for these reasons, a qc analysis from in-depth scans will follow to try to reconstruct the current geometry and compare it to the design specifications.Update of (b)(6) 2024: the analysis run by the quality control department, with the aid of high-precision 3d coordinate measuring machines, did not evidence abnormal wear in any of the sections.Indeed, a minimum deformation was measured, ad it is fair to assume that the majority of this deviation from the nominal dimensions is due to creep, which does not affect the surroundings of the joint.Therefore, no anomaly has been found.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / E
• Common Device Name: HIP HC LINER
• 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: 19719230
• Report Number: 3005180920-2024-00509
• Device Sequence Number: 8207025
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• 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: 2014
• 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,Followup,Followup
• Report Date (Section B): 08/30/2024

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: 12/31/2018
• Device Catalogue Number: 01.26.3244HCT
• Device Lot Number: 136292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/31/2024; 08/27/2024; 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2014
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG