MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.140 HA COATED LAT STEM SIZE 0; HIP HA COATED LAT STEM

Model Number	01.18.140
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6)2023.Lot 135041: (b)(4) items manufactured and released on 11-dec-2013.Expiration date: 2018-nov-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported cases during the period of review.
Event or Problem Description
At about 8 years and 6 months after the primary surgery, the patient came in reporting pain due to a potted stem and the cause is unknown.The surgeon revised successfully the medacta stem and head with competitor products and revised the medacta liner with a medacta liner.

• Brand Name: STEM: AMISTEM H 01.18.140 HA COATED LAT STEM SIZE 0
• Common Device Name: HIP HA COATED LAT STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17008948
• Report Number: 3005180920-2023-00369
• Device Sequence Number: 15171569
• Product Code: LZO
• UDI-Device Identifier: 07630030804168
• UDI-Public: 07630030804168
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2023
• 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): 05/26/2023

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: 11/30/2018
• Device Model Number: 01.18.140
• Device Catalogue Number: 01.18.140
• Device Lot Number: 135041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown