MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9; CEMENTLESS STEM

Catalog Number	01.39.209
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Disorder (2373)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 april 2018: masterloc reference 01.39.209 cementless ti coated lat stem size 9 lot 162771: (b)(4) items manufactured and released on 20 june 2016.Expiration date: 2021-06-08.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mpact reference 01.32.152dh (k132879) acetabular shell ø52 two-holes lot 160472: (b)(4) items manufactured and released on 25 july 2016.Expiration date: 2021-07-12.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Cocr ball head referece 01.25.025 (k072857) cocr ball head 12/14 ø 32 size xxl +10.5 lot.120552 lot 120552: (b)(4) items manufactured and released on 16 may 2012.Expiration date: 2017-03-31.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mpact reference 01.32.3244hct (k103721) flat pe hc liner ø32/e lot.164664 lot 164664: 18 items manufactured and released on 11 october 2016.Expiration date: 2021-09-26 no anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
About 1 year and a half after primary the surgeon revised the joint for a hip infection.The infection caused a stem loosening.The surgery was completed successfully.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 9
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7439186
• Report Number: 3005180920-2018-00239
• Device Sequence Number: 19122820
• Product Code: LZO
• UDI-Device Identifier: 07630030885693
• UDI-Public: 07630030885693
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: 06/08/2021
• Device Catalogue Number: 01.39.209
• Device Lot Number: 162771
• 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: 03/19/2018
• Initial Report FDA Received Date: 04/18/2018
• 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: 64 YR