MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED SIZE 1; HIP STEM CEMENTED

Catalog Number	01.18.101
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 february 2019: lot 157360: (b)(4) items manufactured and released on 26-jan-2016.Expiration date: 2021-01-13.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.Preliminary investigation performed by packaging manager: based on the pictures received and the breakage experienced we can infer that there were extreme handling conditions that involved the packaging breakage.
Event or Problem Description
During surgery, the outer blister was checked and no holes/ defect were found, while the second blister was found broken and a part of the stem was out of the blister.The surgery was completed with another stem.
Additional Manufacturer Narrative
Visual inspection performed by washing and packaging manager: based on the pictures and the item received and considering the breakage experienced we can infer that there were extreme handling conditions that involved the packaging breakage.

• Brand Name: STEM: AMISTEM C CEMENTED SIZE 1
• Common Device Name: HIP STEM CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8381780
• Report Number: 3005180920-2019-00115
• Device Sequence Number: 11134505
• Product Code: LZO
• UDI-Device Identifier: 07630030803796
• UDI-Public: 07630030803796
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103189
• 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,Followup
• Report Date (Section B): 04/18/2019

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: 01/13/2021
• Device Catalogue Number: 01.18.101
• Device Lot Number: 157360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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