MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.13.103L
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 march 2019: lot 180803: (b)(4) items manufactured and released on 24-may-2018.Expiration date: 2023-05-15.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold, without any another similar reported event.Clinical evaluation performed by medical affairs director: femoral component revision occurred 6 months after cementless total hip arthroplasty in a (b)(6) year old man affected by metabolic bone disease.Radiographic images provided show the presence of a subsided stem, probably undersized and slightly varus, and perhaps affected by a malrotation.The reason for this position cannot be assessed on the basis of a single anteroposterior postoperative x-ray.Patient anatomy or bone morphology may be one reason.We cannot determine whether the cause of the subsidence was the initial position or the metabolic bone disease that prevented secondary fixation of the implant, but there is no reason to suspect a faulty device.
Event or Problem Description
The patient has been revised (using quadra h stem) 6 months after primary surgery due to pain and stem loosening (the stem has subsided), initially the stem was placed in varus position and probably undersized.Contributing factors may also be related to metabolic bone disorder that the patient has suffered from.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8436673
• Report Number: 3005180920-2019-00169
• Device Sequence Number: 2170620
• Product Code: LZO
• UDI-Device Identifier: 07630030803192
• UDI-Public: 07630030803192
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 05/15/2023
• Device Catalogue Number: 01.13.103L
• Device Lot Number: 180803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/20/2019
• 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
• Patient Age: 64 YR
• Patient Weight: 80