MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG; DOUBLE MOBILITY ACETABULAR LINER

Model Number	01.26.2854MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 may 2022.Lot 2013112: (b)(4) items manufactured and released on 22-march-2021.Expiration date: 2026-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857) lot.2012857.Batch review performed on 02 may 2022.Lot 2012857: (b)(4) items manufactured and released on 11-march-2021.Expiration date: 2026-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by clinical affairs specialist.Hip intraprostatic dislocation 3 weeks after index implantation.A dislocation occured of the femoral head from the double mobility liner subsequent to traumatic event.At revision surgery, the surgeon decided to use a longer head to increment joint tension, which may mean that it was not sufficient at index surgery to maintain joint stability.However, dislocation of the double mobility liner from the shell is an unusual event.Once the liner dislocated from the shell the likelihood of the small head coming off the liner increases.Visual inspection performed by r&d project manager.From the received part, it was not possible to notice any particular sign on the explanted liner.A further quality control analysis was required, revealing a slight over-dimensioning of the diameter of retention (of slightly more than 0.1mm), probably due to deformation of the insert during explantation.From the received part it was not possible to determine the root cause of the event with certainty, even if we can deduce that is most probably related to the fall of the patient.
Event or Problem Description
At 3 weeks after the primary, revision surgery due to a dislocation of the head from the liner.The patient was doing a movement backward with the leg and then she fell, but it cannot say if she fell because the hip luxated or if she fell and then the hip luxated.The surgeon revised the liner and head (implanting an xl instead of m).The surgery was completed successfully.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
• Common Device Name: DOUBLE MOBILITY 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: 14485386
• Report Number: 3005180920-2022-00389
• Device Sequence Number: 4808458
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/24/2022

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: 03/10/2026
• Device Model Number: 01.26.2854MHC
• Device Catalogue Number: 01.26.2854MHC
• Device Lot Number: 2013112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White