MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0; HIP CERAMIC BALL HEAD

Catalog Number	01.29.202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unequal Limb Length (4534)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had hip instability due to a leg length discrepancy and the cause is unknown.At about 2 years and 1 month post primary the surgeon revised the medacta head and liner with a new medacta head and liner and revised the medacta cup with a competitor cup.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 may 2024 lot 2113856: (b)(4) items manufactured and released on 05-jan-2022.Expiration date: 2026-12-13.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.Additional implants involved batch review performed on 06 may 2024 on cup: mpact 01.32.150mb double mobility acetabular shell ø50 (k143453) lot.2111691 lot 2111691: 120 items manufactured and released on 08-mar-2022.Expiration date: 2027-07-27.No anomalies found related to the problem.To date, 110 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 06 may 2024 on liner: mpact dm 01.26.2850mhc double mobility hc liner 28/dme (k092265) lot.2118106 lot 2118106: 110 items manufactured and released on 01-feb-2022.Expiration date: 2027-01-19.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.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0
• Common Device Name: HIP 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: 19392538
• Report Number: 3005180920-2024-00341
• Device Sequence Number: 7799458
• Product Code: LZO
• UDI-Device Identifier: 07630030809132
• UDI-Public: 07630030809132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 01.29.202
• Device Lot Number: 2113856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2022
• 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 Sex: Unknown