MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2014-11-14 for TIBIAL COMP KIN HINGE KNEE 64753933 manufactured by Stryker Orthopaedics-mahwah.
[5012573]
It was reported that patient had left knee revision due to broken bearing component.
Patient Sequence No: 1, Text Type: D, B5
[12558433]
The sales rep indicated that there will be no further information, implants, x-rays, or medical records due to hospital policy. A supplemental report will be submitted upon completion of the investigation. Device not available.
Patient Sequence No: 1, Text Type: N, H10
[28697266]
The patient is (b)(6) in height. An event regarding a fracture involving a krh tibial bearing component was reported. The event was not confirmed. 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.
Patient Sequence No: 1, Text Type: N, H10
[28697267]
It was reported that patient had left knee revision due to broken bearing component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2014-04277 |
| MDR Report Key | 4251310 |
| Report Source | 00,05 |
| Date Received | 2014-11-14 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-12-10 |
| Device Manufacturer Date | 1999-11-12 |
| Date Added to Maude | 2014-11-14 |
| 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 | 2014-11-14 |
| Catalog Number | 64753933 |
| Lot Number | GIDFE |
| ID Number | STER. LOT 99316 |
| Device Expiration Date | 2004-11-30 |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2014-11-14 |