MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI 646704 LF FRT PAR TEMP; CUSTOM MADE DEVICE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/11/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint # (b)(4).Foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision due to epidural bleeding.The surgeon stated that the need for a revision was due to patient compliance and not a fault of the device.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint # (b)(4).Foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a revision due to epidural bleeding.The surgeon stated that the need for a revision was due to patient compliance and not a fault of the device.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It was reported the wound healing disturbance was caused by high skin tension.It was also reported the surgeon said this was the result of patient compliance rather than a product-related issue.The patient had post-operative difficulties due to epidural bleeding.This could not be confirmed without medical records.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.

Event Description

No further event information available at the time of this report.

• Brand Name: HTR-PMI 646704 LF FRT PAR TEMP
• 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: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13568513
• MDR Text Key: 285928399
• Report Number: 0001032347-2022-00052
• Device Sequence Number: 1
• Product Code: KKY
• UDI-Device Identifier: 00888233049092
• UDI-Public: (01)00888233049092(17)241111(10)076860
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PM624580
• Device Lot Number: 076860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male