MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS COLLARED SOLID STEM LAT SIZE 6; HIP STEM

Model Number	01.36.166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 3 months, the patient came in reporting pain and the cause of the pain is unknown.The surgeon revised the stem and head and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21 march 2021.Lot 2101372: (b)(4) items manufactured and released on 12-april-2021.Expiration date: 2026-06-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional component involved: ball heads: mectacer 01.29.214 biolox delta ceramic ball head 12/14 ø 40 size l + 4 (k112115) lot.2105997: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: STEM: SMS SOLID SMS COLLARED SOLID STEM LAT SIZE 6
• Common Device Name: HIP 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: 16713258
• Report Number: 3005180920-2023-00248
• Device Sequence Number: 1791555
• Product Code: LZO
• UDI-Device Identifier: 07630345701886
• UDI-Public: 07630345701886
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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: 06/21/2026
• Device Model Number: 01.36.166
• Device Catalogue Number: 01.36.166
• Device Lot Number: 2101372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White