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

Model Number	01.18.102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 14 january 2019: lot 180035: (b)(4) items manufactured and released on 04-may-2018.Expiration date: 2023-04-23.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 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 breakage.
Event or Problem Description
During surgery, it was noticed that the second blister was broke (primary packaging).The surgeon decided to use another stem to complete the surgery.
Additional Manufacturer Narrative
On 26-feb-2020 device was returned to medacta.Visual inspection performed by packaging and washing manager: based on the analysis, implant, and packaging, we can infer that there were extreme handling conditions that resulted in the packaging damage.

• Brand Name: AMISTEM C CEMENTED LAT 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: 8252594
• Report Number: 3005180920-2018-01098
• Device Sequence Number: 19410071
• Product Code: LZO
• UDI-Device Identifier: 07630030803802
• UDI-Public: 07630030803802
• 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): 03/26/2020

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: 04/23/2023
• Device Model Number: 01.18.102
• Device Catalogue Number: 01.18.102
• Device Lot Number: 180035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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