MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø48 TWO-HOLES; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.32.148DH
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on november 17, 2017: partial hip revision surgery (cup and liner) occurred 8 months after primary total hip arthroplasty due to luxation occurred during hip flexion.According to the report, the reason is probably linked to the primary surgery.Dislocation is normally due to suboptimal component positioning or insufficient soft tissue tension, it can hardly be caused by standard devices.In this case, we have one intraoperative image, which is hardly appropriate to judge component positioning; however, the cup appears to have almost no anteversion.The reason for this surgical choice is not reported; this may have an influence on joint stability.Batch review performed on 27 november 2017: lot 165372: (b)(4) items manufactured and released on 04 october 2016.Expiration date: 2021-09-22.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.Liner: mpact flat pe hc liner ø32/c ref.01.32.3239hct lot.165913 (k103721): (b)(4) items manufactured and released on 02 november 2016.Expiration date: 2021-10-18.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.
Event or Problem Description
Revision surgery due to subluxation during flexion 8 months after primary, probably due to retroverted cup.The surgeon revised the cup and liner.

• Brand Name: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7067346
• Report Number: 3005180920-2017-00706
• Device Sequence Number: 16168604
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 09/22/2021
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 165372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/29/2017
• 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: 53 YR