MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12; CEMENTLESS HIP STEM

Catalog Number	01.39.212
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 10 january 2019.Lot 162136: 17 items manufactured and released on 31 may 2016.Expiration date: 2021-05-22 no anomalies found related to the problem.To date, 6 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by packaging and washing manager on january 11, 2019, the root cause relates to the combined factors of anomalous shipping/handling conditions and the limitation of the packaging configuration to be optimally robust to all possible shipping stresses experienced.
Event or Problem Description
During the primary hip surgery, it was discovered that the stem had penetrated the external packaging.There was no backup stem available, so the surgeon chose to wash and implant the stem into the patient.

• Brand Name: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8239790
• Report Number: 3005180920-2018-01085
• Device Sequence Number: 16539815
• Product Code: LZO
• UDI-Device Identifier: 07630030885723
• UDI-Public: 07630030885723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2021
• Device Catalogue Number: 01.39.212
• Device Lot Number: 162136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/11/2019
• 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: Other