MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE3; CEMENTED HIP STEM

Catalog Number	01.18.153
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	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 december 2018: lot 182786: (b)(4) items manufactured and released on 24 july 2018.Expiration date: 2023-07-11.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.Preliminary investigation performed by washing and packaging manager on the pictures provided: based on the pictures received and the breakage experienced we can infer that there were extreme handling conditions that caused the packaging breakage.
Event or Problem Description
The primary packaging was found broken during surgery, a back-up implant has been used.White foams, stem and blocker were in the correct position into the blister.The secondary packaging was not damaged.
Additional Manufacturer Narrative
Visual inspection performed by washing and packaging manager: based on the packaging received it is likely there was an event that caused a damage to the packaging, independent of the packaging configuration itself.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE3
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8178704
• Report Number: 3005180920-2018-01012
• Device Sequence Number: 11094563
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• 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): 04/17/2019

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: 07/11/2023
• Device Catalogue Number: 01.18.153
• Device Lot Number: 182786
• 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: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 04/17/2019
• 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