MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMB; DOUBLE MOBILITY ACETABULAR LINER

Model Number	01.26.2244MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Dizziness (2194)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-mar-2021 lot 1909373: (b)(4) items manufactured and released on 12-dec-2019.Expiration date: 2024-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: cocr 01.25.124 cocr ball head 12/14 ø 22 size s -2,5 (k080885) lot.1910793.Batch review performed on 15-mar-2021.Lot 1910793: (b)(4) items manufactured and released on 16-mar-2020.Expiration date: 2025-03-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: a few months after dual mobility tha is performed, the patient falls and suffers a pelvic fracture.Shortly after, intraprosthetic dislocation occurs and requires revision.The clinical analysis cannot tell if the intraprosthetic dislocation occurred because of a consequence of the trauma (e.G., during physiotherapy or rehabilitation), therefore technical analysis of the explants is required to give a possible explanation.No conclusion can be drawn at this stage.Visual inspection performed by r&d project manager: from the received parts, signs were noticed on the internal concave surface of the metal converter, probably related to a third body presence.Also, on the final part of the tapered rim of the dm converter, a polished surface was noticed, that probably occurred after the extraction of the converter from the shell.The polythene dm liner was analyzed, showing the presence of particles on its surface, possibly parts of coating detached from the outer surface of the cup; in addition, the inner constrained diameter of the liner was analyzed by quality control, revealing a small oversize condition of about 0.1mm: from the received information, this slight deviation may be related to the repeated extraction and insertion of the head, that caused some deformation of the device.Regarding the femoral ball head, its surface was scratched by the presence of third body particles.From the received components and the related information, we can conclude that it is not possible to determine a root cause of the event, but the fall and the fracture of the pelvis might be possible factors that brought to the dislocation of the femoral ball head.
Event or Problem Description
Revision surgery performed 7 months after the primary surgery due to intra-prosthetic dislocation between the cocr head and the high cross double mobility liner.Previously the patient fell after a dizzy spell in (b)(6) 2020 and incurred a pelvic fracture.A close reduction of the hip was performed at that moment.After the revision surgery, the head was coupled with the liner again and tried to remove it by hand, but it was not possible.The implants were thoroughly washed and left in alcohol for an hour since sterilization was not possible to be performed.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMB
• Common Device Name: DOUBLE MOBILITY ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11503405
• Report Number: 3005180920-2021-00212
• Device Sequence Number: 2843970
• Product Code: LZO
• UDI-Device Identifier: 07630030806803
• UDI-Public: 07630030806803
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K131458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2021

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: 11/30/2024
• Device Model Number: 01.26.2244MHC
• Device Catalogue Number: 01.26.2244MHC
• Device Lot Number: 1909373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/17/2021
• 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