MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L; HIP DELTA CERAMIC BALL HEAD

Catalog Number 01.29.206

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 february 2024.Lot 2005402: (b)(4) items manufactured and released on 09-09-2020.Expiration date: 2025-08-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other device involved: batch review performed on 28 february 2024.Liner: versafitcup cc trio 01.26.3244hct flat pe hc liner ø 32 / e (k103352) lot 2213349: (b)(4) items manufactured and released on 25-july-2022.Expiration date: 2027-07-07.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.

Event Description

Revision surgery for leg length discrepancy at about 1 year and 2 months from primary.Head and liner revised successfully.

• Brand Name: BALL HEADS: MECTACER 01.29.206 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L
• Type of Device: 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: 18965632
• MDR Text Key: 338431105
• Report Number: 3005180920-2024-00147
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809170
• UDI-Public: 07630030809170
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112115
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.29.206
• Device Lot Number: 2005402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2020
• 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
• Patient Weight: 85 KG
• Patient Race: White