inforMED
InjuryKKY

HTR-PMI 646704 LF FRT PAR TEMP

Received Feb 21, 2022 · Event occurred Dec 11, 2021

Report 0001032347-2022-00052 · MDR key 13568513

Device

Generic name

Custom Made Device

Model number

N/A

Catalog number

PM624580

Lot number

076860

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

54 YR · Male

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Additional 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.

Description of Event or Problem

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.

Additional 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.

Description of Event or Problem

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.

Additional 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.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.