TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
Report
- Report Number
- 0001032347-2025-00079
- Event Type
- Injury
- Date Received
- February 10, 2025
- Report Date
- March 31, 2025
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LZD
- UDI-DI
- 00841036036584
- PMA / PMN Number
- P020016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 01-6546 (723810A). ASSOCIATED PRODUCT INFORMATION: 91-2710 (UNKNOWN) QTY 5, 99-6577 (UNKNOWN) QTY 4, 99-6589 (UNKNOWN) QTY 1. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B6; D2; G1; G3; G6; H1; H2; H3; H6. THE REPORTED EVENT IS CONFIRMED, BASED ON MEDICAL RECORDS. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL (B6). A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT A PATIENT WITH A LEFT TEMPOROMANDIBULAR JOINT IMPLANT PLACED APPROXIMATELY SIX (6) YEARS AND SEVEN (7) MONTHS AGO HAS EXPERIENCED ONGOING DENTAL ISSUES, RANGE OF MOTION LIMITATIONS, AND DISCOMFORT. FOR APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS, THE PATIENT HAS BEEN ON A SOFT DIET DUE TO PERSISTENT SYMPTOMS WITHOUT IMPROVEMENT. THE PATIENT UNDERWENT A PROCEDURE TO ADDRESS EXPOSED BONE IN THE GUMS AT AN UNKNOWN TIME. THE PATIENT REPORTS SEVERE PAIN ASSOCIATED WITH DENTURES, NECK DISCOMFORT, EARACHE-LIKE SYMPTOMS, AND HEADACHES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS FURTHER REPORTED THAT A PATIENT UNDERWENT A REVISION OF LEFT TMJ ARTHROPLASTY PRODUCTS DUE TO A RECALL OF COMPETITOR PRODUCTS APPROXIMATELY SIX (6) YEARS AND NINE (9) MONTHS AGO. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED DROOLING ASSOCIATED WITH NUMBNESS AND A DROOPING EYELID. A FEW YEARS LATER, THE PATIENT DEVELOPED INCREASED PAIN, SWELLING, DEVIATION IN MOUTH OPENING, AND FATIGUE WITH CHEWING PRIOR TO A TEETH EXTRACTION SURGERY. AFTER THE EXTRACTION, THE LEFT SYMPTOMS RESOLVED, BUT THE PATIENT BEGAN EXPERIENCING COMPLICATIONS WITH THE CONTRALATERAL JAW, WHICH DOES NOT CONTAIN IMPLANTS, INCLUDING JAW DISCOMFORT, NECK INVOLVEMENT, EARACHES, AND HEADACHES. RADIOGRAPHIC IMAGING SHOWS ALL IMPLANTS REMAIN IN PLACE WITH NO EVIDENCE OF COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 959785 | TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL | JOINT, TEMPOROMANDIBULAR, IMPLANT | LZD | BIOMET MICROFIXATION | 789950C | 00841036036584 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | H11. |