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 2019-05-01 for MCK TIBIAL ONLAY INSERT-SZ 5-8MM 180705-1 manufactured by Mako Surgical Corp..
[143804860]
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-lm-rl-sz 5; cat# 180505; lot# 535896-m. Mck tibial baseplate-lm/rl-sz 5; cat# 180605; lot# 26071017-01. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[143804861]
It was reported that the patient's left knee was revised due to suspected infection. A size 5x8 restoris onlay tibial insert was swapped out. Rep reported that no further information will be released by the hospital operating room surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2019-00325 |
| MDR Report Key | 8571498 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-05-01 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-05-30 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2019-05-01 |
| 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 ONLAY INSERT-SZ 5-8MM |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
| Product Code | NPJ |
| Date Received | 2019-05-01 |
| Catalog Number | 180705-1 |
| Lot Number | 12020218-1 |
| 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 | 2019-05-01 |