MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-11-13 for TIBIAL COMP KIN HINGE KNEE 64753933 manufactured by Stryker Orthopaedics-mahwah.
[15818646]
On (b)(6) 2014, a patient (name withheld) had an issue with the gmrs or mrh knee replacement. The patient's femur was fine, but the tibia failed. A sales representative stated that the new components of this product would fit into the old femur; however, they did not. The surgeon had to use multiple 14-year old components in order to finish up the patient's procedure. The patient is now at a higher risk for infection and other complications due to this. Update as per sales rep, doa (b)(6) 2014: it was reported that the patient was revised due to poor bone quality which led to the tibia becoming loose (there was no product failure). During the revision surgery, the gmrs bushings provided were not compatible with the femur. The old bushings from the primary surgery had to be used to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
[15958222]
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[28087185]
An event regarding tibial component loosening due to poor bone quality involving a krh tibial rotating component was reported. Conclusion: the investigation is addressed in pr for the krh all-poly tibial component. The tibial rotating component does not interface with bone, it is seated into the all-poly tibial component which does interface with the tibial bone. Based on the provided information, product reported in this investigation did not contribute to the event.
Patient Sequence No: 1, Text Type: N, H10
[28087186]
On (b)(6) 2014, a patient (name withheld) had an issue with the gmrs or mrh knee replacement. The patient's femur was fine, but the tibia failed. A sales representative stated that the new components of this product would fit into the old femur; however, they did not. The surgeon had to use multiple 14-year old components in order to finish up the patient's procedure. The patient is now at a higher risk for infection and other complications due to this. Update as per sales rep, doa (b)(6) 2014: it was reported that the patient was revised due to poor bone quality which led to the tibia becoming loose (there was no product failure). During the revision surgery, the gmrs bushings provided were not compatible with the femur. The old bushings from the primary surgery had to be used to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2014-04253 |
| MDR Report Key | 4247837 |
| Report Source | 00,05 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-11-27 |
| Date Added to Maude | 2014-11-13 |
| 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 | MS. BEVERLY LIMA |
| 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 | 2014-11-13 |
| Catalog Number | 64753933 |
| Lot Number | UNKNOWN |
| 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. Required No Informationntervention | 2014-11-13 |