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 2019-09-30 for ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT N/A 42522100110 manufactured by Zimmer Biomet, Inc..
[160847453]
(b)(4). Concomitant medical products: persona femur cruciate retaining (cr) catalog 42502206402 lot 64071413, nexgen complete knee solution, trabecular metal patella catalog 00587806532 lot 64176468, natural tibia trabecular metal fixed bearing right size d catalog 42530006702 lot 62869826. The product will not be returned to zimmer biomet for investigation as it remains implanted. 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: 0001822565-2019-04181, 0001822565-2019-04182.
Patient Sequence No: 1, Text Type: N, H10
[160847455]
A patient enrolled in a clinical study underwent right knee arthroplasty and was noted to have stiffness and decreased range of motion during their one month follow-up visit. Patient underwent a manipulation under anesthesia approximately two weeks later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2019-04181 |
| MDR Report Key | 9134990 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-30 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2019-09-04 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2019-09-30 |
| 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 | ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | OIY |
| Date Received | 2019-09-30 |
| Model Number | N/A |
| Catalog Number | 42522100110 |
| Lot Number | 63753017 |
| 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. Required No Informationntervention | 2019-09-30 |