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

Model Number	01.26.3248HCT
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During an xrays control, it was noticed that osteolysis is present around the stem (greater trochanter) and the head is not in the middle of the poly liner.Stem and liner were revised 7 years and 10 months after primary.
Additional Manufacturer Narrative
Batch review performed on 28 april 2022: lot 140099: (b)(4) items manufactured and released on 19-feb-2014.Expiration date: 2019-01-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Additional device involved: batch review performed on 28 april 2022: stem: amistem h 01.18.144 ha coated lat stem size 4 (k093944) lot 133083: (b)(4) items manufactured and released on 09-oct-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: 8 years after primary cementless tha, significant osteolytic damage is visible on xrays around the femoral stem, which became loose.The head is in a slightly eccentric position, which suggests that polyethylene wear may have generated debris-induced osteolysis.This may be verified at revision surgery.Significant wear of a highly crosslinked insert after 8 years is abnormal.Analysis of the explants is necessary to verify if a third body can have caused the abnormal wear or if the head was damaged.An update can be done if the explants are received and analyzed.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d project manager: during the visual inspection it has been noticed that part of the stem body is covered with ha coating meaning that the stem was not correctly osseointegrated with the patient bone.Some signs and scratches are present on the neck surface probably due to revision surgery.It is not possible to determine the root cause of this event.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC Ø 32 / F
• Common Device Name: HIP SHELL 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: 14494536
• Report Number: 3005180920-2022-00394
• Device Sequence Number: 17592196
• Product Code: LZO
• UDI-Device Identifier: 07630030807619
• UDI-Public: 07630030807619
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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): 07/07/2022

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: 01/31/2019
• Device Model Number: 01.26.3248HCT
• Device Catalogue Number: 01.26.3248HCT
• Device Lot Number: 140099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2014
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White