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 2015-11-25 for TIBIAL COMP KIN HINGE KNEE 64753933 manufactured by Stryker Orthopaedics-mahwah.
[32182350]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy. Additional information has been requested. Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[32182351]
Patient stated they had a fall. After x-rays were taken it was stated that the rotating component had broken.
Patient Sequence No: 1, Text Type: D, B5
[36727934]
An event regarding a fracture involving a krh tibial bearing component was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as no items were returned. -medical records received and evaluation: not performed as no medical information was provided. -device history review: all devices accepted into final stock conformed to specification. -complaint history review: there have been no other events for the lot referenced. Conclusions: the reported event cannot be confirmed or a root cause determined with the limited information provided. Further information such as device return, x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. No further investigation for this event is possible at this time. If devices and / or additional information become available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[36727935]
Patient stated they had a fall. After x-rays were taken it was stated that the rotating component had broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-04082 |
| MDR Report Key | 5251324 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2015-11-25 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-11-05 |
| Date Mfgr Received | 2015-12-17 |
| Device Manufacturer Date | 2000-12-31 |
| Date Added to Maude | 2015-11-25 |
| 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. KEYLA NAVEDO |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-LIMERICK |
| Manufacturer Street | RAHEEN BUSINESS PARK |
| Manufacturer City | LIMERICK NA |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIBIAL COMP KIN HINGE KNEE |
| Generic Name | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, TRUNNION-BEARING |
| Product Code | LGE |
| Date Received | 2015-11-25 |
| Catalog Number | 64753933 |
| Lot Number | IFKY |
| Device Expiration Date | 2005-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-25 |