MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED LAT STEM SIZE 3; CEMENTED HIP STEM

Catalog Number	01.18.103
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 102962: 40 items manufactured and released on 14 october 2010.Expiration date: (b)(6) 2015.No anomalies found related to the issue.To date, 37 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 the sales representative has been informed by the surgeon that a revision surgery will be performed.At this time we do not know if the reason of the revision surgery is bone fracture or stem loosening.
Additional Manufacturer Narrative
3 years after primary hybrid tha a revision is required.Reasons are not specified; we assume the hip became painful.From the xray analysis, the one source of information to conduct an investigation, we observe that cementation technique was probably suboptimal, and distance is visible between the cement mantle and the distal endosteum.We cannot judge how influential this circumstance could have been on the loosening or pain source.The level of the distal femoral plug is also questionable, it is not shown in the radiograph and we are assuming it existed.

• Brand Name: AMISTEM C CEMENTED LAT STEM SIZE 3
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7291620
• Report Number: 3005180920-2018-00085
• Device Sequence Number: 19056090
• Product Code: LZO
• UDI-Device Identifier: 07630030803819
• UDI-Public: 07630030803819
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 01.18.103
• Device Lot Number: 102962
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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: Required Intervention