MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-06 for TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT N/A 24-6546 manufactured by Biomet Microfixation.
[178001557]
Zimmer biomet complaint (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. The device will not be returned for analysis as it remains implanted in the patient; 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: 0001032347-2020-00088, 0001032347-2020-00090, 0001032347-2020-00091, 0001032347-2020-00092, 0001032347-2020-00093, 0001032347-2020-00094, 0001032347-2020-00095. Medical products: tmj system right standard mandibular component, part# 24-6545, lot# 183570, tmj system left standard mandibular component, part# 24-6546, lot# 174120, tmj system right fossa component, small, part# 24-6562, lot# 216350, tmj system left fossa component, small, part# 24-6563, lot# 190720, 2. 4mm system high torque (ht) cross-drive screw, part# 91-2708, lot# unk, 2. 4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, tmj system cross drive fossa screw, part# 99-6579, lot# unk, tmj system cross drive fossa screw, part# 99-6581, lot# unk. Occupation: patient.
Patient Sequence No: 1, Text Type: N, H10
[178001558]
It was reported the patient underwent a revision surgery due to heterotopic bone growth and dislocation involving bilateral temporomandibular joint prostheses. The patient was received stock implants over a decade ago, and currently reports limited range of motion, headaches, pain and swelling. Fifteen months ago, the patient reported heterotopic ossification in the joint and implant dislocation on the right side. Thirteen months ago, the patient reported a revision surgery in which the existing implants were re-positioned. Trigger point injections and nerve blocks have been inadequate regarding pain management. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00089 |
| MDR Report Key | 9677217 |
| Report Source | CONSUMER |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER DELANEY |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT |
| Generic Name | JOINT, TEMPOROMANDIBULAR, IMPLANT |
| Product Code | LZD |
| Date Received | 2020-02-06 |
| Model Number | N/A |
| Catalog Number | 24-6546 |
| Lot Number | 174120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-02-06 |