MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-23 for TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4 N/A 00584200402 manufactured by Zimmer Biomet, Inc..
[185976197]
(b)(4). Concomitant medical products: item#:00584201502; femoral component high flex precoat lot#: 61975145. Item#:00584202409; articular surface size 4 9 mm height lot#: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01035. 0001822565-2020-01033.
Patient Sequence No: 1, Text Type: N, H10
[185976198]
It was reported by patients legal counsel the patient underwent a right unicompartmental knee arthroplasty and was revised approximately 7 years later due to pain, radiolucency, femoral component fracture, loosening, and osteolysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01034 |
| MDR Report Key | 9865513 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2011-08-22 |
| Date Added to Maude | 2020-03-23 |
| 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 | TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 4 |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | HSX |
| Date Received | 2020-03-23 |
| Model Number | N/A |
| Catalog Number | 00584200402 |
| Lot Number | 61859767 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-23 |