MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-06-29 for BIOMET ILOK PRI TIB TRAY 67MM 141212 manufactured by Biomet Orthopedics.
[78765264]
(b)(6). Medical product: vngd ti fem cr 62. 5mm rt, cat#: cp113616 lot#: 505350. Biomet i-beam pri stem 40mm, cat#: 141310 lot#: 452920. Vngd ant stblzd brg 18x67, cat#: 189048 lot#: 146020. Consumer has indicated that the product will not be returned [location unknown at this time] to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr 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: 0001825034-2017-04472, 0001825034-2017-04473, 0001825034-2017-04474, 0001825034-2017-04476. Product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[78765265]
It is reported that the patient underwent knee arthroplasty revision due to experiencing implant loosening after a car accident. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[113546983]
This follow-up report is being submitted to relay additional information. 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 of the reported event is attributed to patient injury caused by a car accident. 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 | 0001825034-2017-04472 |
| MDR Report Key | 6678760 |
| Report Source | CONSUMER |
| Date Received | 2017-06-29 |
| Date of Report | 2017-10-20 |
| Date of Event | 2011-10-20 |
| Date Mfgr Received | 2017-10-19 |
| Device Manufacturer Date | 2010-04-30 |
| Date Added to Maude | 2017-06-29 |
| 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 PRI TIB TRAY 67MM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2017-06-29 |
| Catalog Number | 141212 |
| Lot Number | 998860 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-06-29 |