MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M

Model Number	01.29.205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years and 4 months after primary, the patient came in reporting pain and the cause is unknown.The surgeon revised the medacta stem and head with a competitor stem and head and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 16-apr-2025 lot 174703: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 18-sep-2022.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.Other devices involved: liner: mpact 01.32.3248hct flat pe hc liner ø32/f (k103721) lot 168468: (b)(4) items manufactured and released on 07-mar-2017.Expiration date: 14-feb-2022.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.Stem: amistem-h prox.Coat.01.18.182 amistem-h proximal coating lat.Size 2 (k161635) lot 167939: (b)(4) items manufactured and released on 16-feb-2017.Expiration date: 08-feb-2022.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.Based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M
• 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: 21974794
• Report Number: 3005180920-2025-00375
• Device Sequence Number: 9274512
• 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: 2017
• Device Explanted Year: 2025
• 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): 05/06/2025

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 Expiration Date: 09/18/2022
• Device Model Number: 01.29.205
• Device Lot Number: 174703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2017
• 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