MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5; CEMENTLESS HIP STEM

Catalog Number	01.13.105L
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem and head) occurred 1 month after cementless total hip arthroplasty in a (b)(6) year old man due to stem subsidence.The stem looks slightly undersized.The reason of this choice is not known: bone morphology or particular patient anatomy may be one possibility but this cannot be confirmed as no preoperative radiographic image is available.The reason of this event cannot be determined.Batch review performed on 10 january 2019.Lot: 179123: (b)(6) items manufactured and released on 14 march 2018.Expiration date: 2023-03-05.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery 1 month after primary surgery.The stem was too deep inside the femoral bone.Stem and head were revised.The stem looks slightly undersized based on radiographic analysis.
Additional Manufacturer Narrative
Device available for investigation received on the 21 november 2019 and analysed by medacta r&d hip project manager: fully intact ha layer on the stem, femoral neck is scratched due to head removal, signs of removal and metal transfer dots on the ceramic head, bone residual on the stem.As discussed during visual inspection performed on nov 26, there is no need to reopen the complaint as the root cause is the same.

• Brand Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8239869
• Report Number: 3005180920-2018-01090
• Device Sequence Number: 2153997
• Product Code: LZO
• UDI-Device Identifier: 07630030803239
• UDI-Public: 07630030803239
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2019

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: 03/05/2023
• Device Catalogue Number: 01.13.105L
• Device Lot Number: 179123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 74 YR