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

Model Number	01.18.152
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 january 2021: lot 163117: (b)(4) items manufactured and released on 06-july-2016.Expiration date: 2021-06-27.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 1-1-2017.
Event or Problem Description
On (b)(6) 2021 (4 years after first revision due to pain performed on (b)(6) 2017; stem and head revised), the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem and head with competitor products and revised the medacta liner with a medacta liner.The surgery was completed.Successfully.The patient had a primary hip surgery on (b)(6) 2011.

• Brand Name: STEM: AMISTEM C CEMENTED STD SIZE 2
• Common Device Name: FEMORAL CEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11272378
• Report Number: 3005180920-2021-00076
• Device Sequence Number: 19794002
• Product Code: LZO
• UDI-Device Identifier: 07630030804274
• UDI-Public: 07630030804274
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• 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): 02/03/2021

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: 06/27/2021
• Device Model Number: 01.18.152
• Device Lot Number: 163117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/03/2021
• 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