MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED LAT STEM SIZE 3; HIP CEMENTED STEM

Catalog Number	01.18.103
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 years and 3 months after primary, the patient has been revised because of stem loosening.Stem, ball head and liner have been revised successfully.Note: the surgeon commented that a possible cause of the insufficient integration in the cement was the high activity of the patient since early.
Additional Manufacturer Narrative
Batch review performed on 23-oct-2023: lot 130131: (b)(4) items manufactured and released on 07-mar-2013.Expiration date: 2018-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed on 8 november 2023 by medacta medical manager: revision performed 8 years and 3 months after primary tha, due to stem loosening.From the radiographic image, it appears that the cement mantle on the lateral side may have become deficient but, not having previous images, we cannot determine if this is a result of an evolutionary process or if it was the situation at postoperative control.The elevated activity of the patient may have contributed to mobilization starting from a situation where stem fixation was dubius.The reason of this failure cannot be determined but there is no reason to suspect a faulty device.

• Brand Name: AMISTEM C CEMENTED LAT STEM SIZE 3
• Common Device Name: HIP CEMENTED 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: 18139034
• Report Number: 3005180920-2023-00877
• Device Sequence Number: 12758097
• Product Code: LZO
• UDI-Device Identifier: 07630030803819
• UDI-Public: 07630030803819
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 11/15/2023

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: 01/31/2018
• Device Catalogue Number: 01.18.103
• Device Lot Number: 130131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2013
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White