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

Catalog Number	01.26.3239HCT
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2018: lot 155383: (b)(4) items manufactured and released on 03 december 2015.Expiration date: 2020-11-18.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs (b)(4) on 24 may 2018: two years after primary hybrid tha a revision surgery was performed, reportedly due to psoas impingement with the acetabular cup.This situation should not be attributed to a faulty device.Visual inspection performed by r&d product manager on 24 may 2018; on the ceramic femoral head, some slight signs can be noted on both the internal and external surfaces.They were probably caused during the revision surgery.On the liner, a sign relative to the insertion of a screw can be noted: it was plausibly inserted to extract the liner during the revision surgery.Two damaged portions can be noted on the base of the liner and on its internal surface.On the external surface around the pole, lipid absorption can be noted.Our cq department is performing dimensional controls on the part.To date, no conclusions can be drawn.
Event or Problem Description
Revision of ball head and liner 2 years after primary due to psoas impingement.Intraoperative clinical status looks like infected, histology macrophage infiltration, but the pathology results came back negative (no infection).Surgeon commented that he found debris from the inlay during the revision.
Additional Manufacturer Narrative
The cq department performed on 24 may 2018 a dimensional controls on the insert with the following outcome: "the nominal value of the internal ø should be 32.3 with tolerance range [0; -0.2].The insert exceeds the nominal value, but never more than a tenth in terms of thickness (ø 32.5).

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 32 / C
• Common Device Name: FLAT LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544740
• Report Number: 3005180920-2018-00367
• Device Sequence Number: 1862886
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: 11/18/2020
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 155383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR