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

Catalog Number	01.32.3648HCT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2024-00068
• Device Sequence Number: 7231418
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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): 02/28/2024

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: 11/26/2023
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 188902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2018
• 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: 68 YR
• Patient Sex: Male