MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.18.182
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 september 2018.Lot 173533: (b)(4) items manufactured and released on 22 march 2017.Expiration date: 2022-11-13.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.
Event or Problem Description
On (b)(6) 2018 we were informed that the patient came in complaining of pain.The surgeon believes the stem is loose.The surgeon plans to revise the patient on (b)(6) 2018.
Additional Manufacturer Narrative
Update received on november 05, 2018.The patient canceled the surgery on (b)(6) 2018 and stated that it was possible he's going elsewhere.No further information was provided and no other records are available.

• Brand Name: AMISTEM-H PROXIMAL COATING LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7854960
• Report Number: 3005180920-2018-00665
• Device Sequence Number: 13735594
• Product Code: LZO
• UDI-Device Identifier: 07630030804472
• UDI-Public: 07630030804472
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: 11/13/2022
• Device Catalogue Number: 01.18.182
• Device Lot Number: 173533
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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