MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER HEAD BIOLOX OPTION 28; HIP CERAMIC HEAD

Model Number	01.29.230H
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 july 2020: lot 1904670: (b)(4) items manufactured and released on 11-sep-2019.Expiration date: 2024-09-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2015.Subsequently, the patient came in reporting pain and on (b)(6) 2020, the surgeon revised the medacta cup and liner with another company's product and revised the medacta head with a medacta head.Presently (4 months after previous surgery), the patient came in reporting pain due to a dislocation of the medacta head from the competitor's liner.The surgeon revised all implants with another company's product and the surgery was completed successfully.

• Brand Name: MECTACER HEAD BIOLOX OPTION 28
• Common Device Name: HIP CERAMIC HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10294912
• Report Number: 3005180920-2020-00953
• Device Sequence Number: 2624615
• Product Code: LZO
• UDI-Device Identifier: 07630030809323
• UDI-Public: 07630030809323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: 09/01/2024
• Device Model Number: 01.29.230H
• Device Catalogue Number: 01.29.230H
• Device Lot Number: 1904670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR