MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE; HIP ACETABULAR SHELL Ø52 TWO-HOLE

Model Number	01.38.052DH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting groin pain and the cause is unknown.The surgeon believed that a loose acetabular implant was present.During the revision surgery (at about 2 years and 5 months from primary), however, the surgeon noted that the joint was stable and the cup was difficult to remove.The surgeon did observe that there was circumferential bony ingrowth as he removed the cup.The surgeon revised the medacta cup, liner, and screws with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.No comment from the surgeon about a possible reason of patient's pain.The surgeon has no reason/theory about what the cause of the pain was.
Additional Manufacturer Narrative
Batch review performed on 06 february 2023: lot 1903153:(b)(4) items manufactured and released on 05-jul-2019.Expiration date: 2024-05-22.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Other devices involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot 1909759: (b)(4) items manufactured and released on 25-mar-2020.Expiration date: 2025-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2000182: (b)(4) items manufactured and released on 20-mar-2020.Expiration date: 2025-05-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Screws: mpact 01.32.6530 cancellous bone screw, flat head ø 6,5 l 30 (k103721) lot 2001168: (b)(4) items manufactured and released on 24-mar-2020.Expiration date: 2025-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: CUP: MPACT 3D METAL 01.38.052DH ACETABULAR SHELL Ø52 TWO-HOLE
• Common Device Name: HIP ACETABULAR SHELL Ø52 TWO-HOLE
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16435539
• Report Number: 3005180920-2023-00104
• Device Sequence Number: 12624414
• Product Code: LPH
• UDI-Device Identifier: 07630030812590
• UDI-Public: 07630030812590
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/19/2020

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: 05/22/2024
• Device Model Number: 01.38.052DH
• Device Catalogue Number: 01.38.052DH
• Device Lot Number: 1903153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2019
• 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: Female