MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.13.102R
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 july 2019: lot 169043: (b)(4) items manufactured and released on 09-may-2017.Expiration date: 2022-04-27.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 manager: partial hip revision surgery (stem, head and liner) performed 7 months after cementless total hip arthroplasty in a (b)(6) year old woman.According to the report, the reason for revision is leg length difference due to severe scoliosis that cannot be confirmed on the basis of the partial x-ray image provided.Explant pictures show the presence of bone on the stem surface suggesting good osseointegration and fixation of the stem.On the basis of information available, there is no reason to suspect that this event is due to a faulty device.Preliminary investigation performed by r&d project manager: preliminary visual investigation shows stem covered in bio fluids and massive bone stock adhesion on the lateral side.Additional implants involved, batch review performed on 04 july 2019.Ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot.183349.Lot 183349: (b)(4) items manufactured and released on 18-sep-2018.Expiration date: 2023-09-04.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.Liner: mectacer 01.29.409 ceramic liner ø 32 / d lot.165467 (device not distributed in the usa).Lot 165467: (b)(4) items manufactured and released on 06-dec-2016.Expiration date: 2021-11-22.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.
Event or Problem Description
On (b)(4) 2019 we were alerted of a revision performed on (b)(6) 2019.Revision surgery has been performed 6 months after primary due to leg length discrepancy, 15 mm (apparently due to severe scoliosis of the spine).Through a posterior approach the surgeon removed the stem, liner and head.He replaced these explanted items with an mpact hooded liner and a competitor revision stem and head.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8789471
• Report Number: 3005180920-2019-00613
• Device Sequence Number: 13911386
• Product Code: LZO
• UDI-Device Identifier: 07630030803185
• UDI-Public: 07630030803185
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 04/27/2022
• Device Catalogue Number: 01.13.102R
• Device Lot Number: 169043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/15/2019
• 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: 55 YR
• Patient Weight: 70