MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-06 for BIOMET FINNED PRI STEM N/A 141314 manufactured by Zimmer Biomet, Inc..
[177944608]
(b)(4). Concomitant medical products: vanguard cr ilok fem-rt catalog # 183006 lot # 6494487, vngd ant stab brg catalog # 189061 lot # 959300, series a pat std catalog # 184764 lot # 069360. The complainant has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 0001825034-2020-00471, 0001825034-2020-00473, 0001825034-2020-00474. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[177944609]
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient experienced a syncopal episode at home which resulted in a laceration to the nasal bridge of nose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2020-00472 |
| MDR Report Key | 9675820 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-02-06 |
| 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 | 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 FINNED PRI STEM |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | OIY |
| Date Received | 2020-02-06 |
| Model Number | N/A |
| Catalog Number | 141314 |
| Lot Number | 284360 |
| 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. Other; 2. Required No Informationntervention | 2020-02-06 |