MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 3; CEMENTED STEM

Catalog Number	01.18.153
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 january 2019.Lot 155671: (b)(6) items manufactured and released on 16 december 2015.Expiration date: 2021-01-26.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been already sold without any similar reported event.Inspection performed by packaging and washing manager: based on the pictures received and the breakage experienced we can infer that there were extreme handling conditions that involved the packaging.
Event or Problem Description
During the primary hip surgery, it was discovered that there was a hole in the external packaging of the size 3 amistem c.There was a five minute delay in the case while the agent checked his inventory for another size 3 amistem c.The surgeon had to implant a size 4 amistem c due to the size 3 not being available and the surgery was completed successfully.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 3
• Common Device Name: CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8277557
• Report Number: 3005180920-2019-00005
• Device Sequence Number: 1912097
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• 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
• Report Date (Section B): 01/25/2019

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: 01/26/2021
• Device Catalogue Number: 01.18.153
• Device Lot Number: 155671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/25/2019
• 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