MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø36/F; HIP SHELL LINER

Catalog Number 01.32.3648HCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05-feb-2024: lot 188902: (b)(4) manufactured and released on 10-dec-2018.Expiration date: 2023-11-26.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Additional devices involved: batch reviews performed on 05-feb-2024: ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (b)(6) lot 186551: (b)(4) manufactured and released on 15-nov-2018.Expiration date: 2023-11-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Stem: amistem p 01.18.403 amistem-p std stem size 3 (b)(6) lot 1810239: (b)(4) manufactured and released on 04-apr-2019.Expiration date: 2024-03-18.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 4 years and 10 months after primary, the patient came in reporting pain after tripping and feeling a pop several months before the revision date.During the revision at the distal part of the stem the bone was very hard and this was probably due to a femoral bone fracture that has healed, but not noticed before.The stem was explanted using medacta stem removal system and was easy to remove it.Implanting the new stem, flexible reamers were needed to perform distal femur reaming because of the hard bone likely due to the healed bone fracture.The surgeon revised the medacta stem and head with competitor products and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: MPACT FLAT PE HC LINER Ø36/F
• Type of Device: HIP SHELL LINER
• 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: 18795922
• MDR Text Key: 336395636
• Report Number: 3005180920-2024-00068
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 188902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male