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

Model Number	01.18.152
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 155290: (b)(4) items manufactured and released on 10 november 2015.Expiration date: 2020-10-26.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The nurse opened the implant carton box and the first sterile blister in which the stem was contained.She checked it and there were no holes.Only at the opening of the second blister she found that it was seriously damaged.It was broken and pieces of the blister were on the side of the implant.The surgeon decided to use another implant, the surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2020 we have received the item involved in the event 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: STEM: AMISTEM C CEMENTED STD STEM SIZE 2
• Common Device Name: HIP CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8707237
• Report Number: 3005180920-2019-00477
• Device Sequence Number: 19429901
• 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,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: 10/26/2020
• Device Model Number: 01.18.152
• Device Catalogue Number: 01.18.152
• Device Lot Number: 155290
• 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: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/18/2019
• 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