MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 11; CEMENTLESS STEM

Catalog Number	01.39.011
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 september 2019: lot 167506:10 items manufactured and released on 13-mar-2017.Expiration date: 2022-03-01.No anomalies found related to the problem.To date, 3 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by packaging and washing manager: it was concluded that the damage evidently occurred due to forces experienced during transportation/handling.This was indicated to be correlated to the packaging configuration that allows degrees of freedom for movement within the package.The damage is probably the results of the forces experienced during transportation/handling and consequently the rubbing between stem and the plastic blister.
Event or Problem Description
During the primary hip surgery, the scrub nurse observed white material on the implant and a hole in the primary packaging.It was observed that also the outer package was cracked.The or team removed the implant, everything that touched it and opened more instruments/implant.This event caused a 45-minute delay in the case.The surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 11
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9171538
• Report Number: 3005180920-2019-00850
• Device Sequence Number: 2158349
• Product Code: LZO
• UDI-Device Identifier: 07630030885600
• UDI-Public: 07630030885600
• 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): 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 01.39.011
• Device Lot Number: 167506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/09/2019
• 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