MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT; REVISION CEMENTLESS HIP STEM

Model Number	01.22.008
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-feb-2021.Lot 155512: (b)(4) items manufactured and released on 30-mar-2017.Expiration date: 2021-10-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.Additional implant involved: stem: m-vizion 01.22.164 distal stem ø15mm l 220mm straight (k191816) lot.1901251.Batch review performed on 23-feb-2021.Lot 1901251: (b)(4) items manufactured and released on 30-oct-2019.Expiration date: 2024-10-20.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold.No other similar events have been reported.Clinical evaluation performed by medical affairs director.Hip revision surgery performed 6 months after implantation of a modular cementless stem in a difficult case with significant bone loss and a partially resected femur.The patient reported pain and instability probably due to leg length discrepancy.Early stem subsidence may be caused by undersizing or poor bone quality: in this difficult case sizing is extremely difficult as the purchase of the stem in the canal is very dishomogeneous, so it may be holding in a very limited section which may then give way once loading is applied.Radiographic images provided don't allow a full evaluation of the case.No reason to suspect a defective device.
Event or Problem Description
The patient came in reporting pain and instability about 7 months after primary.Post-op x-rays indicated that the stem had subsided and a physical examination revealed a leg length discrepancy of greater than 1 cm.The surgeon revised the proximal body ø20mm l 50mm lat with a 01.22.030 proximal body ø24mm l 70mm lat and revised the 40mm biolox delta head xl with a 01.29.213 40mm biolox delta head m.The surgery was completed successfully.The patient had good bone quality.The surgeon kept in the original distal stem from the primary (01.22.164 distal stem ø15mm l 220mm straight 1901251).The distal reamer used was a size -15mm.

• Brand Name: STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT
• Common Device Name: REVISION CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11371403
• Report Number: 3005180920-2021-00135
• Device Sequence Number: 14462406
• Product Code: LZO
• UDI-Device Identifier: 07630030877148
• UDI-Public: 07630030877148
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 10/19/2021
• Device Model Number: 01.22.008
• Device Catalogue Number: 01.22.008
• Device Lot Number: 155512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/24/2021
• 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