MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.39.004
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018; lot 164826: (b)(4) items manufactured and released on 17 october 2016.Expiration date:2021-10-06 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.Other device involved: cocr ball head 12/14 ø 36 size l +3.5 reference 01.25.032 (k080885); lot 172871: (b)(4) items manufactured and released on 26 september 2017.Expiration date: 2022-09-11 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.
Event or Problem Description
The same day of the surgery the patient was reopened for stem rotation inside the femoral canal.Stem and head swap.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7549086
• Report Number: 3005180920-2018-00380
• Device Sequence Number: 13896987
• Product Code: LZO
• UDI-Device Identifier: 07630030885532
• UDI-Public: 07630030885532
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: 10/17/2016
• Device Catalogue Number: 01.39.004
• Device Lot Number: 164826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/29/2018
• 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: Disability
• Patient Age: 69 YR