MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-02-06 for BIOMET ILOK STEM TIB TRAY 67MM N/A 141512 manufactured by Biomet Orthopedics.
[66656087]
Concomitant medical products: item name: e1 vngd as tib brg 10x63, item number: ep-189020, lot number: 225960. Item name: biomet tib block 6mm 67, item number: 141742, lot number: 930680. This report is number 1 of 3 mdrs filed for the same patient (reference 0001825034-2017-00480/00481).
Patient Sequence No: 1, Text Type: N, H10
[66656088]
It was reported the patient was revised for tibial loosening.
Patient Sequence No: 1, Text Type: D, B5
[74267694]
Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-00478 |
| MDR Report Key | 6305768 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-02-06 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-01-09 |
| Date Mfgr Received | 2017-04-14 |
| Device Manufacturer Date | 2013-04-02 |
| Date Added to Maude | 2017-02-06 |
| 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 | 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 | BIOMET ORTHOPEDICS |
| 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 STEM TIB TRAY 67MM |
| Generic Name | PROTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-02-06 |
| Model Number | N/A |
| Catalog Number | 141512 |
| Lot Number | 944320 |
| ID Number | N/A |
| Device Expiration Date | 2018-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-02-06 |