MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-09-11 for KINMTC ROT HINGE SHRT TIB BEAR 64858435 manufactured by Stryker Orthopaedics-mahwah.
[16082342]
It was reported that the patient had swelling of the right knee. Patient has krh hinge. Upon exploration it was discovered that the post going into the baseplate was fractured. The surgeon replaced bushings, poly, rotating component, axle, and bumper.
Patient Sequence No: 1, Text Type: D, B5
[16444253]
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Patient retained device.
Patient Sequence No: 1, Text Type: N, H10
[31195416]
Manufacturing date and expiration date corrected. An event regarding a fracture involving a krh tibial bearing component was reported. The event was not confirmed. Device evaluation not performed as no items were returned. Medical not performed as insufficient medical information was provided. The clinical consultant commented that it is not possible to establish a root cause of failure based upon the current information. 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. The exact cause of the event could not be determined because insufficient information was received. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.
Patient Sequence No: 1, Text Type: N, H10
[31195417]
It was reported that the patient had swelling of the right knee. Patient has krh hinge. Upon exploration it was discovered that the post going into the baseplate was fractured. The surgeon replaced bushings, poly, rotating component, axle, and bumper.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2014-03447 |
| MDR Report Key | 4081142 |
| Report Source | 00,05 |
| Date Received | 2014-09-11 |
| Date of Report | 2014-08-21 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-10-03 |
| Device Manufacturer Date | 2002-01-04 |
| Date Added to Maude | 2014-09-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. NIKU KASMAI |
| 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 | KINMTC ROT HINGE SHRT TIB BEAR |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2014-09-11 |
| Catalog Number | 64858435 |
| Lot Number | IDBD |
| Device Expiration Date | 2007-01-31 |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2014-09-11 |