MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø56 TWO-HOLES

Catalog Number	01.32.156DH
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2018.Lot 162963: 50 items manufactured and released on 16 june 2016.Expiration date: 2021-05-29 no anomalies found related to the problem.To date, 49 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by (b)(4) director on 23 may 2018.Acetabular component revision due to cup loosening occurred 1.5 years after primary cementless total hip arthroplasty in an (b)(6) (bmi 37) (b)(6) woman.The shell looks anteverted and protruding in the pelvis; radiolucent lines are also visible suggesting mobilization of the cup.Immediate postoperative implant position cannot be assessed as no x-ray is available.From the surgeon's report it appears that the original position was suboptimal and in his opinion concurred significantly to the loosening: if the initial position is analogous to the final one we agree that it may be a determinant cause for failure.The reasons that led to such positioning are not known, but an obese patient represents a challenge from the surgical point of view.
Event or Problem Description
On (b)(6) 2018 we were informed that patient presented to surgeon with painful hip from previous surgery.Xrays revealed lucent line around cup.Subsection of cup loosening.Revision surgery booked for (b)(6).On (b)(6) 2018 the revision surgery was performed.The surgeon revised the patient for cup loosening.Cup, liner and head swap.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7536830
• Report Number: 3005180920-2018-00349
• Device Sequence Number: 13918614
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• 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
• Report Date (Section B): 05/23/2018

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: 05/29/2021
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 162963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• 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: 63 YR
• Patient Weight: 109