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 2019-12-02 for BMT 360 TIB 5.0 OFFSET ADAPTER N/A 185211 manufactured by Zimmer Biomet, Inc..
[168780642]
(b)(4). Concomitant medical products: vanguard ssk 360 left femur catalog 185288 lot 2823216, vanguard 360 femoral augment catalog 185428 lot 115580, vanguard 360 femoral augment catalog 185428 lot 354980, biomet splined knee stem catalog 148306 lot 731640, biomet 360 tibial tray catalog 185206 lot 184200, biomet splined knee stem catalog 148306 lot 277800, biomet 360 offset adapter catalog 185211 lot 497570, vanguard ssk tibial bearing catalog 185104 lot 985950, unknown cobalt bone cement. Customer has not indicated whether the product will be returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[168780643]
It was reported the patient underwent a left knee revision arthroplasty approximately three years post implantation due to pain and loosening of the femoral components. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2019-05419 |
| MDR Report Key | 9397766 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-12-02 |
| Date of Report | 2020-03-30 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2014-12-23 |
| Date Added to Maude | 2019-12-02 |
| 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 | BMT 360 TIB 5.0 OFFSET ADAPTER |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2019-12-02 |
| Model Number | N/A |
| Catalog Number | 185211 |
| Lot Number | 497570 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-12-02 |