MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-05 for MCK TIBIAL ONLAY INSERT-SZ 6-8MM 180706-1 manufactured by Mako Surgical Corp..
[180583655]
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. The following devices were also listed in this report: mck femoral component; cat# unk_ofl; lot# unknown. Mck tibial component; cat# unk_ofl; lot# unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Patient Sequence No: 1, Text Type: N, H10
[180583656]
It was reported that the patient's right knee was revised. Rep was not present for the procedure, but was provided pictures of a mako mck tibial onlay insert which was worn/ delaminated on top. Patient's entire pka construct was revised to a tka construct.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2020-00075 |
| MDR Report Key | 9670952 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2013-10-15 |
| Date Added to Maude | 2020-02-05 |
| 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. 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 ONLAY INSERT-SZ 6-8MM |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY |
| Product Code | NPJ |
| Date Received | 2020-02-05 |
| Model Number | 180706-1 |
| Catalog Number | 180706-1 |
| Lot Number | 12030613 |
| Device Expiration Date | 2018-10-31 |
| 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 | 2020-02-05 |