MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI 1500889 RT FRT; CUSTOM MADE DEVICE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G2: foreign - germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a revision occurred due to an unknown reason.Attempts have been made and no further information has been provided.

Event Description

It was reported that the patient received a cranial implant approximately two and a half years ago.Subsequently, the patient underwent a revision approximately one year ago due to an epidural infection.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

After receiving additional information and final investigation review, this event was found to be not reportable as this event was found to be unrelated to the implanted zimmer biomet device.The initial report should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.E1: the surgeons associated with this event are l.Tanrikulu and a.Benescu.The following sections were updated: a1; b4; b5; e1; g3; g6; h1; h2; h3; h6; h10 upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HTR-PMI 1500889 RT FRT
• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17867397
• MDR Text Key: 324871661
• Report Number: 0001032347-2023-00367
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00888233035583
• UDI-Public: (01)00888233035583(17)240302(10)029030
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: N/A
• Device Catalogue Number: PM623881-A
• Device Lot Number: 029030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization