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

Model Number	01.26.3244STT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at 4 years and 9 months after primary due to osteolysis that caused the stem mobilization, liner wear suspected by the surgeon.Stem, head and liner were revised.
Additional Manufacturer Narrative
Batch review performed on 14-dec-2021: lot 165946: (b)(4) items manufactured and released on 21-nov-2016.Expiration date: 2021-11-06.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Visual inspection liner: the liner showed no particular signs, except for the hole performed by the extraction screw and a slightly yellowed dome external surface.The piece was analyzed by quality control, revealing a small over-dimensioning of the inner spherical surface; in particular, diameter and head center was almost 0.25mm and 0.5 respectively above specifications, and also a slight deformation was noticed.After the analysis of the piece, we cannot exclude that a small wear could occurred, being the device a not crosslinked polyethylene; however, the deformations of the liner could be totally or partially related to other several causes, like impaction, extraction and eventual sterilization of the device.Clinical evaluation: hip revision surgery performed 4 years and 9 months after primary cementless total hip arthroplasty in an elderly lady ((b)(6) years old).The pre-revision x-ray shows a proximal femur significantly osteoporotic and areas of bone resorption that may be the result of osteolytic activity that could have been triggered by polyethylene wear or by other pathological causes not reported.The analysis of explants is needed to verify the possible presence of a third body that may have multiplied wear.No definitive conclusion can be reached with the information at hand.Other device involved: batch review performed on 22 december 2021: stem: amistem h 01.18.131 ha coated std stem size 1 (k093944)lot 164598: (b)(4) items manufactured and released on 02-nov-2016.Expiration date: 2021-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Visual inspection stem: during the analysis it is evaluated that approximately first proximal half of the stem body is covered with ha coating.This in unexpected meaning a not correctly osseointegration with patient bone.Some bone residuals are present on the stem distal part.Some signs and scratches are present on the neck part, probably due to revision surgery.It is not possible to determine the root cause of reported complaint.

• Brand Name: LINER: CC E CC LIGHT FLAT PE Ø 32
• Common Device Name: ACETABULAR 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: 13060041
• Report Number: 3005180920-2021-01018
• Device Sequence Number: 19189161
• Product Code: LZO
• UDI-Device Identifier: 07630030807589
• UDI-Public: 07630030807589
• 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: 2017
• Device Explanted Year: 2021
• 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): 12/22/2021

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: 11/06/2021
• Device Model Number: 01.26.3244STT
• Device Catalogue Number: 01.26.3244STT
• Device Lot Number: 165946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• 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: 89 YR
• Patient Sex: Female