MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-17 for MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM 180735-1 manufactured by Mako Surgical Corp..
[145369593]
The following devices were also listed in this report: mck tibial baseplate-lm/rl-sz 5 catalogue number -180605 lot number - 26470917-01. Mck femoral-lm-rl-sz 5 - catalogue number - 180505 lot number - 549084-m. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[145369594]
The doctor performed an i&d poly exchange on a mako partial knee due to infection. Original surgery was (b)(6) 2018. The i&d was performed on the (b)(6) 2018. On the 22/april/2019 the rep provided implant/ usage sheets for primary and subsequent two revisions and reported that no further information will be released by the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2019-00366 |
| MDR Report Key | 8619526 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-04-18 |
| Date Mfgr Received | 2019-04-19 |
| Device Manufacturer Date | 2018-10-12 |
| Date Added to Maude | 2019-05-17 |
| 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 | MS. ANNA RYAN |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal | NA |
| Manufacturer Phone | 61498200 |
| 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 | MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
| Product Code | NPJ |
| Date Received | 2019-05-17 |
| Catalog Number | 180735-1 |
| Lot Number | TKOP27 |
| 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 | 2019-05-17 |