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 2020-03-05 for MCK TIBIAL BASEPLATE-RM/LL-SZ 6 180616 manufactured by Mako Surgical Corp..
[182780481]
An event regarding pain 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 remained implanted medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components. 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 primary operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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
[182780482]
This pi is for the implants used in patient 2 of 3. (b)(6) yo female, surgery (b)(6) 2019. As reported by surgeon: attached are xrays of three patients i previously discussed. All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op. Thus far, none have required revision but all have some degree of pain (mostly medial). Again i never saw this prior the mics transition. Let me know your thoughts and if any other surgeons have seen this issue. More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better. Case type: pka 3. 0.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2020-00141 |
| MDR Report Key | 9794038 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-05 |
| 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 6 |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
| Product Code | NPJ |
| Date Received | 2020-03-05 |
| Model Number | 180616 |
| Catalog Number | 180616 |
| Lot Number | 26100416-01 |
| 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. Other | 2020-03-05 |