MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-05-14 for MCK TIBIAL BASEPLATE-LM/RL-SZ 6 180606 manufactured by Mako Surgical Corp..
[145001302]
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[145001303]
During the cementing of the final implants, dr. Suspected a potential fracture in the tibia. He made a comment about the blue tip breaking off of the tibial baseplate impactor while he was sliding the impactor from the posterior part of the baseplate to anterior and that some of the final impactions may have been metal on metal. He put in the femoral and insert trials and placed the leg in extension with an axial load to fully seat the cemented tibia baseplate rather than continue to use an impactor. He noticed the tibial checkpoint seemed loose and was easily able to pull it out. Once removed, he was able to confirm there was a fracture and ordered an x-ray. An x-ray confirmed a fracture from the tibia plateau extending to where the position of the tibia checkpoint was seated. Dr. Suspects the fracture propagated at the tibial keel and worked its way anterior to the lateral side of the peg and down to the checkpoint, although he was not able to confirm it went to the keel because the implant was already cemented down. A trauma surgeon was called in to repair the fracture. Following this, alignment was checked in kinematic analysis as well as walking the green probe over the baseplate in the implant planning page. Dr. Was still happy with the alignment and final numbers, noting that we may have lost roughly 0. 5-1 degree of varus due to the fracture. The leg alignment with trials was 4-4. 5 degrees varus and the post-fracture was 5-5. 5 degrees of varus, corrected from an original native deformity of 7-7. 5 degrees of varus. An additional comment was made following the case that warm cement was used, which is not commonly his preference, which may have rushed the process of cementing the final implants. Case type: tka, surgical delay 30-60 minutes, this complaint is for the tibial impactor and tibial baseplate. Update: patient was under anesthesia and delay of surgery approximately one hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2019-00361 |
| MDR Report Key | 8608735 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-05-14 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-06-13 |
| Date Added to Maude | 2019-05-14 |
| 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-LM/RL-SZ 6 |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
| Product Code | NPJ |
| Date Received | 2019-05-14 |
| Catalog Number | 180606 |
| Lot Number | 26321017-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-14 |