MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S; HIP BALL HEAD

Catalog Number	01.29.201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-feb-2024.Lot: 2309196: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-04-10.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 additional implant involved, batch review performed on 22-feb-2024.Liner: versafitcup dm 01.26.2848mhc double mobility hc liner ø 48/28 (k092265) lot: 2307524: (b)(4) items manufactured and released on 09-jun-2023.Expiration date: 2028-05-28.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 or Problem Description
At about 5 months after primary, the patient has been revised on the right hip side because of leg length discrepancy.Ball head and double mobility liner were revised successfully.

• Brand Name: BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S
• Common Device Name: 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: 18911150
• Report Number: 3005180920-2024-00113
• Device Sequence Number: 17902979
• Product Code: LZO
• UDI-Device Identifier: 07630030809125
• UDI-Public: 07630030809125
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/15/2024

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 Catalogue Number: 01.29.201
• Device Lot Number: 2309196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White