MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2015-03-27 for HMRS ROT HINGE TIB ROT COMP 64832250 manufactured by Stryker Orthopaedics-mahwah.
[5611237]
Dr. (b)(6) performed revision surgery as patient had a kotz rotating component which had broken.
Patient Sequence No: 1, Text Type: D, B5
[13059166]
The event involves a device that is not cleared for sale in the u. S. , but similar device is commercially available in the u. S. When completed, the investigation results will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[31824146]
An event regarding component fracture involving an hmrs tibial rotating component was reported. The event was confirmed. Method & results: device evaluation and results: the post of the tibial rotating component broke in fatigue with the fracture progressing from the posterior side to the anterior side. The base metal was found to be a co, cr, mo and si alloy consistent with astm f75 material. No material or manufacturing defects were observed on the device features examined. Medical records received and evaluation: not performed as medical records were not provided. Device history review: the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for the lot referenced. Conclusions: the exact cause of the event could not be determined due to insufficient provision of information. Further information such as: x-rays, operative reports as well as patient history and follow up notes are needed to complete the investigation to determine root cause.
Patient Sequence No: 1, Text Type: N, H10
[31824147]
Dr. (b)(6) performed revision surgery as patient had a kotz rotating component which had broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-00944 |
| MDR Report Key | 4638404 |
| Report Source | 00,05 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-03 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-05-07 |
| Device Manufacturer Date | 2004-09-15 |
| Date Added to Maude | 2015-03-27 |
| 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 | HMRS ROT HINGE TIB ROT COMP |
| Generic Name | IMPLANT |
| Product Code | HSH |
| Date Received | 2015-03-27 |
| Returned To Mfg | 2015-03-18 |
| Catalog Number | 64832250 |
| Lot Number | LXNIK |
| ID Number | STERILE LOT# E9171 |
| Device Expiration Date | 2009-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-03-27 |