MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.232
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 178476: (b)(4) items manufactured and released on 09 april 2018.Expiration date: 2023-03-26.No anomalies found related to the issue.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, the scrub tech noticed that the stem packaging was compromised.Secondary blister tyvek pealed back on the corner.The surgeon used another stem to complete the surgery.The surgery was completed successfully and without delay.The packaging was discarded after surgery.

• Brand Name: AMISTEM H STEM COLLARED HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8217192
• Report Number: 3005180920-2018-01065
• Device Sequence Number: 11190120
• Product Code: LZO
• UDI-Device Identifier: 07630030804571
• UDI-Public: 07630030804571
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 03/26/2023
• Device Catalogue Number: 01.18.232
• Device Lot Number: 178476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/04/2019
• 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