MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5; HIP STEM CEMENTLESS

Model Number	01.39.205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 4 years and 5 months after the primary surgery, the patient came in reporting pain due to a leg length discrepancy and the cause is unknown.The surgeon revised the stem and head with competitor components.The stem was revised because the head was already short and it was not possible to go to a shorter one.The surgery was completed successfully.
Additional Manufacturer Narrative
Clinical investigation performed by medical affaird department: revision performed 4 years and 5 months after total hip arthroplasty in a female patient due to pain.According to report, pain is due to a leg length discrepancy, which is theoretically possible but not very common.No radiographic history is available and therefore the evolution of the discrepancy cannot be evaluated.The one radiographic image provided shows only one hip and therefore we cannot estimate the potential contribution of spine deformities or other concomitant abnormalities.The reason of this failure cannot be determined.Batch review performed on 12-sep-2022: lot 166780: (b)(4) items manufactured and released on 08-mar-2017.Expiration date: 2022-02-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 176376: (b)(4) items manufactured and released on 09-jan-2018.Expiration date: 2022-12-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 5
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15526931
• Report Number: 3005180920-2022-00742
• Device Sequence Number: 2507245
• Product Code: LZO
• UDI-Device Identifier: 07630030885655
• UDI-Public: 07630030885655
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• 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): 10/03/2022

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: 02/27/2022
• Device Model Number: 01.39.205
• Device Catalogue Number: 01.39.205
• Device Lot Number: 166780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female