MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI BLUM BI FRT; CUSTOM MADE DEVICE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product - unknown plates catalog#: ni lot#: ni, unknown screws catalog#: ni lot#: ni.The device remains implanted and no part identification was provided.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.Multiple mdr reports were filed for this event, please see associated reports:0001032347-2021-00403, and 0001032347-2021-00404.

Event Description

It was reported that the patient received a cranial implant 14 years ago and is currently experiencing pain.No additional consequences or impact to the patient were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.

Event Description

It was reported that the patient underwent a craniotomy and reconstruction procedure 15 years ago due to a tumor.Subsequently, the patient developed an abscess/osteomyelitis under the cranial flap that had been created and secured with lorenz plating system.Therefore, the patient bone flap and all hardware were removed 14 years ago and the patient was placed on an iv antibiotic.13 years ago, the patient underwent implantation of a prosthetic cranial implant to address the cranial defect that was left after the previous device removal.The patient is now complaining of pain in the reconstructed area.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Supplied photos were reviewed.Photos show individuals forehead area which appear to show raised and lowered areas but, nothing definitive can be determined by the photos.No product was returned; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 BLUM BI 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: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12329093
• MDR Text Key: 266842788
• Report Number: 0001032347-2021-00402
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: N/A
• Device Catalogue Number: PM607841
• Device Lot Number: 501340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2007
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Female