MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-01-07 for TIBIAL COMP KIN HINGE KNEE 64753933 manufactured by Stryker Orthopaedics-mahwah.
[15024950]
It was reported that mrs distal femur with all poly tibia was removed due to infection.
Patient Sequence No: 1, Text Type: D, B5
[15279451]
Additional devices listed in this report: cat 2481-8-010, lot eunha, description: mrs fem rot hinge lft 65mm bod; cat 6495-6-050, lot lbhxa, description: gmrs extension piece 50mm; cat 6495-6-030, lot s74jk, description: gmrs extension piece 30mm. 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 devices are not available for evaluation. Additional information has been requested and if received, will be provided. Product not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[32877978]
An event regarding infection involving a tibial comp kin hinge knee was reported. The event was not confirmed. Device evaluation not performed as no items were returned. Medical evaluation not performed as no medical records were provided. Device history review confirmed all devices accepted into finished goods conformed to specification. Complaint history review. There has been no other events for the reported lot or sterile lot. The exact cause of the event could not be determined based on the limited information provided. Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause. A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting. No further investigation is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[32877979]
It was reported that mrs distal femur with all poly tibia was removed due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2014-00068 |
| MDR Report Key | 3558245 |
| Report Source | 00,05 |
| Date Received | 2014-01-07 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-12-11 |
| Date Mfgr Received | 2014-10-16 |
| Device Manufacturer Date | 2002-04-17 |
| Date Added to Maude | 2014-01-07 |
| 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 | TIBIAL COMP KIN HINGE KNEE |
| Generic Name | IMPLANT |
| Product Code | LGE |
| Date Received | 2014-01-07 |
| Catalog Number | 64753933 |
| Lot Number | KXUR |
| ID Number | STERILE LOT 02107 |
| Device Expiration Date | 2007-04-30 |
| 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 | 2014-01-07 |