MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 36 / F; HIP LINER POLYETHYLENE

Catalog Number	01.26.3648HCT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 july 2024 lot 115192: (b)(4) items manufactured and released on 03-feb-2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department revision 12 years from the primary tha.The surgeon decided to remove the head and pe liner replacing them with similar products.According to report the patient shows visible wear of the polyethylene liner and the cup and some initial femoral osteolysis.With documentation supplied, we cannot confirm these findings.The surgeon however, probably assessing that stem and cup were reliably fixed, only changed head and liner, thus contradicting the osteolysis assessment.No information on the weight/age/activity of the patient are available.We were not given explants to analyze and verify the possible presence of a third body that may have increased wear, and we haven't been able to measure wear for the absence of the explant.However, macroscopic wear is not visible on the liner pictures.Also, no significant signs of femoral osteolysis are visible in the one xray supplied.No definitive conclusion can be reached with the information at hand.Preliminary analysis performed by r&d project manager from he received image, the liner appeared dirty of blood and damaged most probably by the removal during revision surgery.From the received information, it is not possible to establish any type of suspected failure of the device and to determine the root cause of the event.Additional implant revised: batch review performed on 31 july 2024 on stem: quadra-h 01.12.026 cementless, ha coated std stem size 6 (k082792) lot.113023 lot 113023: (b)(4) items manufactured and released on 21-dec-2021.Expiration date: 2016-09-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At approximately 12 years and 4 months after primary surgery, femoral osteolysis and possible liner wear were detected.Revision surgery was performed in which the head and liner were removed and replaced with ceramic head and liner, while the stem and cup were not revised.

• Brand Name: LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 36 / F
• Common Device Name: HIP LINER POLYETHYLENE
• 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: 20022567
• Report Number: 3005180920-2024-00648
• Device Sequence Number: 8748167
• Product Code: LZO
• UDI-Device Identifier: 07630030807688
• UDI-Public: 07630030807688
• 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: 2012
• Device Explanted Year: 2024
• 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): 08/21/2024

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: 12/31/2016
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 115192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2012
• 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 Sex: Unknown