CUSTOM MADE DEVICE MANDEL RIGHT PM-TMJ & MODEL
Report
- Report Number
- 0001032347-2018-00615
- Event Type
- Injury
- Date Received
- September 12, 2018
- Date of Event
- August 17, 2018
- Report Date
- February 21, 2019
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- LZD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00616-1.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00616-1.
THE IMPLANT WAS IMPLANTED (B)(6) 2018 AND EXPLANTED (B)(6) 2018 THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PARTS NOT BEING RETURNED. IT WAS REPORTED THAT THE REASON FOR THE REVISION WAS DUE TO AN EAR CANAL INFECTION THAT SPREAD INTO THE FOSSA COMPONENT CAUSED BY PATIENT'S ANATOMY CHANGED OVER THE YEARS. INFECTION WAS NOT CAUSED BY THE IMPLANT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE TMJ IMPLANT AND ASSEMBLY SCREW AND NO DISCREPANCIES WERE FOUND. DHR REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE PART NUMBER AND LOT NUMBER OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. BASED ON THE INFORMATION AND MATERIALS PROVIDED, THERE WAS NOTHING TO SUGGEST THAT THERE WAS AN ALLEGED MALFUNCTION OR INABILITY OF THE IMPLANTS TO FUNCTION AS INTENDED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00616-2.
IT WAS REPORTED THE REVISION WAS DUE TO AN EAR CANAL INFECTION THAT SPREAD INTO THE FOSSA COMPONENT CAUSED BY PATIENT'S ANATOMY CHANGED OVER THE YEARS. INFECTION WAS NOT CAUSED BY THE IMPLANT.
IT WAS REPORTED THE REVISION WAS DUE TO AN EAR CANAL INFECTION THAT SPREAD INTO THE FOSSA COMPONENT CAUSED BY PATIENT'S ANATOMY CHANGED OVER THE YEARS. INFECTION WAS NOT CAUSED BY THE IMPLANT.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
(B)(4). IMPLANT DATE: "ROUGHLY ON" (B)(6) 2018. CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION 2.5 MM X 8 MM ASSEMBLY SCREW, CATALOG #: CP-1928, LOT #: 799370; BIOMET MICROFIXATION UNKNOWN SCREWS, CATALOG #: NI, LOT #: NI. THERAPY DATE: UNKNOWN. FOREIGN COUNTRY: (B)(6). PMA/510(K) NUMBER: THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS BIOMET MICROFIXATION MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P020016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00616.
IT WAS REPORTED THAT AN EMERGENCY EXPLANTATION OF THE CUSTOM TEMPORAL MANDIBULAR JOINT WILL BE PERFORMED. THE DISTRIBUTOR REPORTED, "THE IMPLANT ITSELF DID NOT FAIL. PATIENT ANATOMY AND BONE QUALITY IS NOT GOOD." ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712185 | CUSTOM MADE DEVICE MANDEL RIGHT PM-TMJ & MODEL | PATIENT MATCHED TEMPOROMANDIBULAR JOINT IMPLANT | LZD | BIOMET MICROFIXATION | N/A | 814820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization| R |