MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S -4; HIP CERAMIC HEAD

Model Number 01.29.204

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 may 2021: lot 180530: (b)(4) items manufactured and released on 20-june-2018.Expiration date: 2023-06-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional devices involved batch reviews performed on 31 may 2021: stem: amistem h 01.18.130 ha coated std stem size 0 (k093944) lot 177141: (b)(4) items manufactured and released on 11-apr-2018.Expiration date: 2023-03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 180650: (b)(4) items manufactured and released on 14-may-2018.Expiration date: 2023-04-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

The patient came in reporting pain 2 years 6 months after the primary and the cause of pain is unknown.The surgeon revised the medacta stem and head with a competitor's product and revised the medacta liner with a medacta liner.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S -4
• Type of Device: HIP CERAMIC HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11999155
• MDR Text Key: 256192321
• Report Number: 3005180920-2021-00497
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030809156
• UDI-Public: 07630030809156
• 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: 06/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: 01.29.204
• Device Catalogue Number: 01.29.204
• Device Lot Number: 180530
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2018
• 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