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

Model Number	01.39.204
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 13 march 2020: lot 168819: (b)(4) items manufactured and released on 16-mar-2017.Expiration date: 2022-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Additional implants involved in the event, batch review performed by medacta regulatory affairs department on 13 march 2020: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.179839.Lot 179839: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Cup: mpact 01.32.148dh acetabular shell ø48 two-holes (k132879) lot.180700.Lot 180700: (b)(4) items manufactured and released on 13-giu-2018.Expiration date: 2023-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar event reported.Liner: mpact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot.179359 lot 179359: (b)(4) items manufactured and released on 17-apr-2018.Expiration date: 2023-04-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Event or Problem Description
The patient came in after 1 year and 6 months after the primary reporting pain and the cause of the pain is unknown.The surgeon revised the stem, head, cup and liner.The surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9914995
• Report Number: 3005180920-2020-00209
• Device Sequence Number: 2612154
• Product Code: LZO
• UDI-Device Identifier: 07630030885648
• UDI-Public: 07630030885648
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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: 03/02/2022
• Device Model Number: 01.39.204
• Device Catalogue Number: 01.39.204
• Device Lot Number: 168819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 04/02/2020
• 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