MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø32/D; HIP FLAT PE HC LINER

Catalog Number	01.32.3241HCT
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 174331: (b)(4) items manufactured and released on 27-nov-2017.Expiration date: 2022-11-15.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.One other device was involved in the complaint ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.175430: (b)(4) items manufactured and released on 08-nov-2017.Expiration date: 2022-10-23.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 medical affairs manager: acetabular component revision surgery occurred 1 year after cementless total hip arthroplasty due to recurrent dislocation.Radiographic image provided shows a slightly vertical acetabular shell but no conclusion on implant position can be drawn on the basis of a single anteroposterior pre-revision x-ray.Hip dislocation may be due to component positioning or insufficient soft tissue tensioning; it can hardly be caused by standard devices.
Event or Problem Description
Revision surgery performed 1 year after primary due to recurrent hip dislocation (head from liner).At the first dislocation, the surgeon was able to reduce her hip without surgery.After the second re-occurrence, the surgeon revised cup, liner and head.The surgery was completed successfully.The primary was performed in amis.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/D
• Common Device Name: HIP FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8478387
• Report Number: 3005180920-2019-00235
• Device Sequence Number: 1104283
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 11/15/2022
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 174331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/03/2019
• 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