MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M; HIP DELTA CERAMIC BALL HEAD

Model Number	01.29.205
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2021.On (b)(6) 2023, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the head and liner and the surgery was completed successfully.Presently, on (b)(6)2023, the patient came in reporting pain after dislocating anteriorly and the cause is unknown.The surgeon revised the medacta cup and liner with a competitor cup and liner and revised the medacta head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 09-jun-2023.Lot: 2217231: (b)(4) items manufactured and released on 21-oct-2022.Expiration date: 2027-10-04.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 other devices involved: liner: mpact 01.32.3239hc10a face-changing 10° pe hc liner ø32/c (k183582) lot: 2009674: (b)(4) items manufactured and released on 28-jan-2021.Expiration date: 2026-01-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two other similar reported cases during the period of review.Cup: mpact 01.32.148sh acetabular shell ø48 no-hole (k132879) lot: 2007363: (b)(4) items manufactured and released on 30-oct-2020.Expiration date: 2025-10-22.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.

• Brand Name: BALL HEADS: MECTACER 01.29.205 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
• Common Device Name: HIP DELTA CERAMIC BALL HEAD
• 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: 17097351
• Report Number: 3005180920-2023-00429
• Device Sequence Number: 1894698
• Product Code: LZO
• UDI-Device Identifier: 07630030809163
• UDI-Public: 07630030809163
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/09/2023

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 Model Number: 01.29.205
• Device Catalogue Number: 01.29.205
• Device Lot Number: 2217231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2022
• 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: 43 YR
• Patient Sex: Male