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

Catalog Number	01.18.152
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	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 12 march 2019: lot 185891: (b)(4) items manufactured and released on 07-nov-2018.Expiration date: 2023-10-25.No anomalies found related to the problem.To date, (b)(4) items of this lot have already been sold without any other similar event reported.Preliminary investigation performed by washing and 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 second blister of the stem was found broke, a part of the stem was out of the packaging.A new stem was used to complete the case.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8416471
• Report Number: 3005180920-2019-00150
• Device Sequence Number: 1954984
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• 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
• Report Date (Section B): 03/13/2019

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: 10/25/2023
• Device Catalogue Number: 01.18.152
• Device Lot Number: 185891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/13/2019
• 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