MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 2; CEMENTED STEM

Catalog Number	01.18.152
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 165585: (b)(4) items manufactured and released on 04-nov-2016.Expiration date: 10/25/2021.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
During the primary hip surgery, it was discovered that the size 2 amistem c sterile packaging was damaged.There was a 5 minute delay in the case and the surgeon swapped to another stem to complete the case.The surgery was completed successfully.
Additional Manufacturer Narrative
Musa informed us that the device is no longer available.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8319902
• Report Number: 3005180920-2019-00039
• Device Sequence Number: 1663758
• Product Code: JWH
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• 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,Followup
• Report Date (Section B): 05/09/2019

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: 10/25/2021
• Device Catalogue Number: 01.18.152
• Device Lot Number: 165585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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