MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-12 for MCK PATELLOFEMORAL-R-SZ 4 180414 manufactured by Mako Surgical Corp..
[147885767]
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
[147885768]
The implant was found contaminated in the packaging at the time of opening for implantation, so we didn't use it and opened a new one. On (b)(6) 2019 update via phone with sales rep: there was no damage noted on the outer blister. The inner blister appeared to have discoloration. The implant also appeared to be discolored. Case type: pka. Surgical delay: x - =15 minutes. Update: "the implant was discovered as faulty immediately upon opening and did not make contact with the patient. The scrub tech did not observe or comment on any tears or openings in the blister packaging prior to opening. The blemish is on the center of the implant in the trochlear groove. It appears as though the metal tarnished in some way. I was not able to wipe or scrape off the blemish using a wipe or tool. It was additionally observed where the inner blister packaging was contacting the blemish, the packaging turned yellow. Right patellofemoral mako".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2019-00424 |
| MDR Report Key | 8691248 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-06-12 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2017-02-17 |
| Date Added to Maude | 2019-06-12 |
| 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 PATELLOFEMORAL-R-SZ 4 |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
| Product Code | NPJ |
| Date Received | 2019-06-12 |
| Returned To Mfg | 2019-05-20 |
| Catalog Number | 180414 |
| Lot Number | 2607851-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Other | 2019-06-12 |