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 2020-01-20 for VAN PS OPEN INTL FEM-RT 62.5 183106 manufactured by Zimmer Biomet, Inc..
[176083198]
(b)(4). Multiple mdr's are associated with this reporting. Please also reference: 1825034-2016-01524. The investigation is in process. Once the investigation has been completed, a follow-up/final report will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[176083200]
It was reported the patient was revised due to cement loosening causing device malposition and allergic reaction. It should be noted the cement is a competitor device. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00308 |
| MDR Report Key | 9607977 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-22 |
| Date of Event | 2015-12-08 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2015-01-13 |
| Date Added to Maude | 2020-01-20 |
| 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 | VAN PS OPEN INTL FEM-RT 62.5 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | MBV |
| Date Received | 2020-01-20 |
| Model Number | 183106 |
| Catalog Number | 183106 |
| Lot Number | 882840 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-20 |