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 2018-12-20 for PATELLO-FEMORAL TROCHLEA COMPONENT PRECOAT N/A 00592601102 manufactured by Zimmer Biomet, Inc..
[131070282]
(b)(4). Concomitant medical products: catalog #: 00584201302, femoral component high flex precoat, lot # 62827179. Catalog #: 00584202408, articular surface size 4, lot # 62697221. Catalog #: 00584200402, tibial component precoat, lot # 62828687. Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to being discarded. 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: 0001822565-2018-07028.
Patient Sequence No: 1, Text Type: N, H10
[131070283]
It was reported that a patient underwent an initial knee procedure on approximately 3 years ago. Subsequently, the patient was revised due to pain, loosening, and instability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-07029 |
| MDR Report Key | 8186449 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2015-02-24 |
| Date Added to Maude | 2018-12-20 |
| 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 | PATELLO-FEMORAL TROCHLEA COMPONENT PRECOAT |
| Generic Name | PROSTHESIS KNEE |
| Product Code | KRR |
| Date Received | 2018-12-20 |
| Model Number | N/A |
| Catalog Number | 00592601102 |
| Lot Number | 62936327 |
| 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 | 2018-12-20 |