MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC, CEMENTLESS TI COATED STEM SIZE 8 LAT; CEMENTLESS FEMORAL STEM

Catalog Number	01.39.208
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 25 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: stem loosening 1 year after primary cementless tha.The information provided does not allow a complete analysis of the case to be carried out; only an intraoperative fluoroscopic image is supplied with no date.The stem there looks subsided, but no postoperative picture is available, so subsidence cannot be quantified and the appropriateness of stem sizing at operation cannot be evaluated.Therefore, the causes for this adverse event cannot be determined.Batch review performed on 28 august 2017.Lot 145328: (b)(4) items manufactured and released on 10 april 2015.Expiration date: 2020-02-29.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 patient came in complaining of pain.The surgeon determined that the stem has become loose.The surgeon explanted the liner, head and stem.The surgery was completed successfully.X-ray are available.

• Brand Name: MASTERLOC, CEMENTLESS TI COATED STEM SIZE 8 LAT
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6837590
• Report Number: 3005180920-2017-00487
• Device Sequence Number: 16346061
• Product Code: LZO
• UDI-Device Identifier: 07630030885686
• UDI-Public: 07630030885686
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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: 02/29/2020
• Device Catalogue Number: 01.39.208
• Device Lot Number: 145328
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/01/2017
• 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: 65 YR