MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2018-08-09 for BIOMET MAXIM PRIMARY TIBIAL TRAY N/A 141210 manufactured by Zimmer Biomet, Inc..
[116549123]
(b)(4). Medical product: catalog #: 183002, vanguard femoral left, lot # 460210. Catalog #: 183402, vanguard tibial bearing, lot # 474000. Catalog #: 184782, series a patella peg, lot # 054040. Catalog #: 141310, biomet i-beam stem, lot # 105650. 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 reports: 0001825034-2018-07499, 07500, 07501, 07502, 07503. Location unknown.
Patient Sequence No: 1, Text Type: N, H10
[116549124]
It was reported that a patient underwent primary total knee arthroplasty approximately 10 years ago. Subsequently, the patient was noted to have pitted edema occurring on an unknown date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2018-07501 |
| MDR Report Key | 7767215 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2018-08-09 |
| Date of Report | 2018-10-10 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2018-08-09 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMET MAXIM PRIMARY TIBIAL TRAY |
| Generic Name | PROSTHESIS KNEE |
| Product Code | MBV |
| Date Received | 2018-08-09 |
| Model Number | N/A |
| Catalog Number | 141210 |
| Lot Number | 806940 |
| Device Expiration Date | 2015-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-09 |