MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-13 for BIOMET ILOK PRIMARY TIBIAL TRAY N/A 141215 manufactured by Zimmer Biomet, Inc..
[85992470]
(b)(4). Concomitant medical products: vanguard custom titanium cruciate retaining femoral, cat#: cp113618, lot#: 170070. Biomet i-beam primary tibial stem, cat#: 141310, lot#: 974490. Vanguard tibial bearing, cat#: ep-183462, lot#: 480970. Biomet series-a standard patella, cat#: 184764 ,lot#: 974490. Cobalt bone cement, cat#: 402283, lot#: 604040. The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted. 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: 0001825034-2017-07020, 0001825034-2017-07022, 0001825034-2017-07078, 0001825034-2017-07079, 0001825034-2017-07080.
Patient Sequence No: 1, Text Type: N, H10
[85992471]
It was reported that the patient was revised to address loosening, infection and wear of components. Intraoperatively, metallosis was noted in the joint and scratches on the femoral component. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07021 |
| MDR Report Key | 6862025 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-13 |
| Date of Report | 2018-08-15 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2012-06-06 |
| Date Added to Maude | 2017-09-13 |
| 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 ILOK PRIMARY TIBIAL TRAY |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-09-13 |
| Returned To Mfg | 2017-08-17 |
| Model Number | N/A |
| Catalog Number | 141215 |
| Lot Number | 977050 |
| ID Number | N/A |
| Device Expiration Date | 2017-05-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-09-13 |