MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S; HIP BALL HEAD

Catalog Number 01.29.208

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Implant Pain (4561)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 24-oct-2023 lot 2303248: (b)(4) items manufactured and released on 08-mar-2023.Expiration date: 2028-02-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported case during the period of review.Additional implants involved, batch review performed on 24-oct-2023: cup: mpact 01.32.152dh acetabular shell ø52 two-holes (k132879) lot 2247879: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-03-26.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.Liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 2248470: (b)(4) items manufactured and released on 02-mar-2023.Expiration date: 2028-02-12.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.

Event Description

At about 2 months and 3 weeks after primary, the patient came in reporting pain due to joint luxation and the cause is unknown.Upon opening the patient, the surgeon also noticed that the cup was anteverted and the cause is unknown.The surgeon revised successfully the cup, head and liner.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S
• Type of Device: HIP 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: 18063574
• MDR Text Key: 327239621
• Report Number: 3005180920-2023-00882
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809194
• UDI-Public: 07630030809194
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.29.208
• Device Lot Number: 2303248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG