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

Model Number	01.18.230
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 september 2020.Lot 141496: 20 items manufactured and released on 12-may-2014.Expiration date: 2019-03-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2016.
Event or Problem Description
The patient came in, 5 years and 11 months after primary surgery, reporting pain due to a potted stem that becomes loose.The cause of the potted stem is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 0
• Common Device Name: CEMENTLESS HIP STEM COLLARED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10641812
• Report Number: 3005180920-2020-00685
• Device Sequence Number: 4044214
• Product Code: LZO
• UDI-Device Identifier: 07630030804557
• UDI-Public: 07630030804557
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: 03/31/2019
• Device Model Number: 01.18.230
• Device Catalogue Number: 01.18.230
• Device Lot Number: 141496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/07/2020
• 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: Required Intervention