MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-11 for MCK TIBIAL BASEPLATE-RM/LL-SZ 4 26740917-01 180614 manufactured by Mako Surgical Corp..
[183771048]
An event regarding subsidence involving a mako baseplate was reported. The event was not confirmed. Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned. Medical records received and evaluation: no medical records were received for review with a clinical consultant. Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies. Complaint history review: there have been no other similar events for the lot referenced. Conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause. No further investigation for this event is possible at this time. If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[183771049]
A restoris partial knee was revised due to the tibia component subsiding. The surgeon decided to replace the tibial component with another restoris, but one size bigger. The poly was also changed from 9 to 10 mm. The primary operation was done on (b)(6) 2019. The revision was done on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2020-00145 |
| MDR Report Key | 9819395 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2020-03-11 |
| 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 | MR. COLLIN NEITZEL |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | MAKO SURGICAL CORP. |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCK TIBIAL BASEPLATE-RM/LL-SZ 4 |
| Generic Name | KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P |
| Product Code | NPJ |
| Date Received | 2020-03-11 |
| Model Number | 26740917-01 |
| Catalog Number | 180614 |
| Lot Number | 26740917-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAKO SURGICAL CORP. |
| Manufacturer Address | 2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-11 |