MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL 62 TWO-HOLES; HIP ACETABULAR SHELL

Model Number	01.32.162DH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 september 2020: lot 157832: (b)(4) items manufactured and released on 22-apr-2016.Expiration date: 2021-04-13.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.Additional device involved.Batch review performed on 14 september 2020 stem: amistem collared 01.18.238 stem collared ha coated std stem size 8 (k121011) lot 172628: (b)(4) items manufactured and released on 28-sep-2017.Expiration date: 2022-09-17.No anomalies found related to the problem.To date, 6 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: few days after primary cementless tha dislocation occurs.The stem is positioned in valgus and possibly undersized.The position of the cup appears suboptimal too, particularly in terms of anteversion.The extremely low quality of the images supplied does not allow a proper evaluation to be carried out.Valgus stem and suboptimal cup anteversion are however likely causes for an early dislocation.No reason to suspect a faulty device.
Event or Problem Description
The patient hip has dislocated (head from liner) twice since the primary surgery on (b)(6) 2020, both times whilst the surgeon was on holiday.The patient needed an urgent revision once he consulted him on his return.The stem was removed and replaced with a competitor stem.The cup was salvaged.The cup introducer was engaged in the cup and the anteversion manually decreased.New 20-degree liner implanted.Patient appeared more stable.During primary: valgus stem placement, ante version on both stem and cup and incorrect choice of offset stem and head, contributed to an inadequate hip offset and successive dislocation.

• Brand Name: MPACT ACETABULAR SHELL 62 TWO-HOLES
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10640899
• Report Number: 3005180920-2020-00689
• Device Sequence Number: 4044213
• Product Code: LPH
• UDI-Device Identifier: 07630030810978
• UDI-Public: 07630030810978
• 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: 2020
• Device Explanted Year: 2020
• 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): 10/07/2020

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: 04/13/2021
• Device Model Number: 01.32.162DH
• Device Catalogue Number: 01.32.162DH
• Device Lot Number: 157832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: 41 YR
• Patient Weight: 120