MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-07-31 for TIBIAL COMP KIN HINGE KNEE 64753933 manufactured by Stryker Orthopaedics-mahwah.
[4626777]
Patient had a primary of left knee in 1995 by dr. (b)(6). Patient then had a revision to replace polyethylene on (b)(6) 2006. Patient is now on second revision of left knee due to loose components. It was reported that the femur and tibia were loose. No further info available due to dr and hospital policy.
Patient Sequence No: 1, Text Type: D, B5
[12066726]
An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report. Hospital policy.
Patient Sequence No: 1, Text Type: N, H10
[28922822]
An event regarding femoral and tibial loosening involving a krh tibial bearing component was reported. The mrs system is a segmental modular system. The reported femoral and tibial loosening would occur at the modular stem / bone interface. Based on the limited information provided, there is no indication or allegation that loosening occurred between the tibial bearing component and its interfacing devices. Other than the modular stem, no other devices interface with bone. There is no indication that the product reported in this investigation may have contributed to the event. No further investigation is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[28922823]
Patient had a primary of left knee in 1995 by dr. (b)(6) patient then had a revision to replace polyethylene on (b)(6) 2006. Patient is now on second revision of left knee due to loose components. It was reported that the femur and tibia were loose. No further info available due to dr and hospital policy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2014-02924 |
| MDR Report Key | 3969937 |
| Report Source | 00,05 |
| Date Received | 2014-07-31 |
| Date of Report | 2014-07-09 |
| Date of Event | 2014-07-09 |
| Date Mfgr Received | 2014-09-05 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2014-07-31 |
| 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 | 2014-07-31 |
| Catalog Number | 64753933 |
| Lot Number | LUWR |
| ID Number | STERILE LOT 02273 |
| Device Expiration Date | 2007-09-30 |
| 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 | 2014-07-31 |