MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM

Catalog Number	01.18.230
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 february 2018: lot 151471: (b)(4) items manufactured and released on 17 september 2015.Expiration date: 2020-09-05.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.
Event or Problem Description
The patient had a primary hip on (b)(6) 2016.On (b)(6) 2016 the patient came in due to feeling unstable.The patient was dislocating.The cup was anteverted.The surgeon revised the cup, head and liner (b)(4).On (b)(6) 2018 the patient was revised again.The patient came in complaining of instability due to stem loosening.The cause is unknown.The surgeon revised the stem, head and liner successfully.

• Brand Name: AMISTEM COLLARED HA COATED STD STEM SIZE 0
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7276716
• Report Number: 3005180920-2018-00058
• Device Sequence Number: 16485852
• Product Code: LZO
• UDI-Device Identifier: 07630030804557
• UDI-Public: 07630030804557
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 09/05/2020
• Device Catalogue Number: 01.18.230
• Device Lot Number: 151471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/16/2018
• 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
• Patient Age: 72 YR