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 2020-03-04 for MCK TIBIAL BASEPLATE-LM/RL-SZ 5 180605 manufactured by Mako Surgical Corp..
[181970409]
An event regarding loosening involving a mako tibial component was reported. The event was not confirmed. Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review. The photographs note the following:the photo displayed a uni femoral component and tibial component with blood and cement on it. Nothing else remarkable to report. Medical records received and evaluation: no medical records were received for review with a clinical consultant. Product history review: not performed as the device lot details were not provided. Complaint history review: not performed as the device lot details were not provided. Conclusions: it was reported that patient's right partial knee was revised due to loosening and cement appeared not to have bonded with native bone. The event could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided. Further information such as 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
[181970410]
Revision of restoris medial unicomp due to loosening. Cement appeared not to have bonded with native bone. Revised to a triathlon total knee.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2020-00136 |
| MDR Report Key | 9786526 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-04 |
| 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. ALESSANDRA CHAVEZ |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal | 33317 |
| Manufacturer Phone | 9546280700 |
| 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-LM/RL-SZ 5 |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY |
| Product Code | NPJ |
| Date Received | 2020-03-04 |
| Catalog Number | 180605 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-04 |