MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7; CEMENTLESS STEM

Catalog Number	01.39.207
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2018; lot 162951: (b)(4) items manufactured and released on 30 june 2016.Expiration date:2021-06-15; no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Preliminary investigation performed on 26 june 2018 by r&d product manager: preliminary visual analysis does not highlight any particular sign of device-related implant failure.Clinical evaluation performed by medical affairs (b)(4) on 10 july 2018: partial hip revision occurred 1 year after primary cementless total hip arthroplasty in a (b)(4) year old man.According to the report, the stem subsided.Initial stem position cannot be assessed not having the immediate postoperative images.The date of subsidence is not known, and the cause cannot be determined with the information at hand.The images of the stem lead to think that no osseointegration took place, but we cannot determine for which reason.
Event or Problem Description
About 1 year after primary the surgeon revised the patient for a stem subsidence.The surgeon replaced successfully the stem and the head.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7685637
• Report Number: 3005180920-2018-00503
• Device Sequence Number: 1398604
• Product Code: LZO
• UDI-Device Identifier: 07630030885679
• UDI-Public: 07630030885679
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 06/15/2021
• Device Catalogue Number: 01.39.207
• Device Lot Number: 162951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/13/2018
• 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: 71 YR