MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT 01.26.2839HCT FLAT PE HC LINER Ø 28 / C; HIP FLAT PE HC LINER

Model Number	01.26.2839HCT
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain in the hip and from the x-ray the surgeon determined that the inlay was not central anymore.At 16 years from primary the surgeon revised successfully the head and liner successfully.
Additional Manufacturer Narrative
Batch review performed on 12 april 2022: lot 051889: (b)(4) items manufactured and released on 24-jan-2006.Expiration date: 2010-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2018.Visual inspection performed by r&d manager: the liner was noticed to be slightly deformed in the head seat, with a thinner part in a portion of the rim; for this reason, a quality control analysis was required.The results of the analysis reported that the inner sphere was enlarged of about 1mm deforming the sphericity.For this reason, it is evident that a deformation of the liner occurred, partially related to wear due to long implant use.Clinical evaluation performed by medical affairs director: a pe insert was used in 2006 on a (b)(6) female patient.After 16 years, wear of the pe liner is visible.Relationship between wear and pain is not straightforward.Cup and stem have probably been found stable by the surgeon who decided not to replace them.Some areas of radiolucencies are visible around the stem, we cannot determine if it is osteolysis.The stem itself after 16 years appears slightly undersized and in a valgus position, but this may be the result of the evolution of the patient's bone.It is also possible that the receding bone around the cup has exposed metal edges which may now be in contact with muscles.A clear explanation for the pain is not possible with the information at hand; it would be important to know how is the patient feeling in the next few weeks.

• Brand Name: LINER: CC E CC LIGHT 01.26.2839HCT FLAT PE HC LINER Ø 28 / C
• Common Device Name: HIP FLAT PE HC LINER
• 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: 14317030
• Report Number: 3005180920-2022-00329
• Device Sequence Number: 5199003
• Product Code: LZO
• UDI-Device Identifier: 07630030807091
• UDI-Public: 07630030807091
• 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: 2006
• Device Explanted Year: 2022
• 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): 05/06/2022

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: 11/30/2010
• Device Model Number: 01.26.2839HCT
• Device Catalogue Number: 01.26.2839HCT
• Device Lot Number: 051889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2006
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White