MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6; STEM CEMENTLESS TI COATED

Model Number	01.39.206
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Joint Dislocation (2374)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 january 2021: lot 163570: (b)(4) items manufactured and released on 25-july-2016.Expiration date: 2021-07-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.Another similar event has been reported.Additional device involved: batch review performed on 18 january 2021: cup: mpact 01.32.150mb double mobility acetabular shell ø50 (k143453)lot.160428: (b)(4) items manufactured and released on 04-april-2016.Expiration date: 2021-03-13.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
Revision surgery due to stem loosening, 4 years 4 months after the primary.Tests showed that the patient had an allergic reaction to nickel.The surgeon revised all components and the surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
• Common Device Name: STEM CEMENTLESS TI COATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11200885
• Report Number: 3005180920-2021-00054
• Device Sequence Number: 14020829
• Product Code: LZO
• UDI-Device Identifier: 07630030885662
• UDI-Public: 07630030885662
• 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: 2016
• Device Explanted Year: 2020
• 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): 01/20/2021

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: 07/11/2021
• Device Model Number: 01.39.206
• Device Catalogue Number: 01.39.206
• Device Lot Number: 163570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/20/2021
• 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