MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-03-13 for FEM STEM-HI OFFSET NK-SIZE 1 IMPLANT 186004-01 manufactured by Stryker Orthopaedics-mahwah.
[20152322]
The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio). During the case, the surgeon fractured the patient's femur while inserting the stem. The patient's femur was cabled and the outcome of the case was successful.
Patient Sequence No: 1, Text Type: D, B5
[20461147]
As part of normal complaint follow-up, an evaluation of the event is being completed at mako surgical. A supplemental report will be filed when additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[35009361]
Clinician review: a review of the provided medical records and x-rays by a clinical consultant concluded: "no patient demographics, no clinical or past medical history, and no operative report are available for review. There is no indication that factors of faulty component design, manufacturing, or materials were responsible for this clinical situation. " device history review of the device based on the reported lot, it was manufactured around 30-nov-2014. Complaint history review there have been no other events for the reported lot. The event was confirmed by the medical records submitted. However, the root cause of the reported event could not be determined due to the minimal information received. No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics. If additional information becomes available, this investigation will be reopened.
Patient Sequence No: 1, Text Type: N, H10
[35009362]
The surgeon performed a makoplasty total hip arthroplasty using the robotic arm interactive orthopedic system (rio). During the case, the surgeon fractured the patient's femur while inserting the stem. The patient's femur was cabled and the outcome of the case was successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005985723-2015-00032 |
| MDR Report Key | 4600139 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-10 |
| Date of Event | 2015-02-10 |
| Date Mfgr Received | 2015-12-09 |
| Device Manufacturer Date | 2014-11-30 |
| Date Added to Maude | 2015-03-13 |
| 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 | 3 |
| Event Location | 3 |
| 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 | MAKO SURGICAL CORP. |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEM STEM-HI OFFSET NK-SIZE 1 IMPLANT |
| Generic Name | HIP JOINT METAL/CERAMIC/POLYMER SEMI-CONSTRAINED CEMENTED OR NONPOROUS UNCEMENTE |
| Product Code | OQI |
| Date Received | 2015-03-13 |
| Catalog Number | 186004-01 |
| Lot Number | 100141-01 |
| Device Expiration Date | 2019-11-30 |
| 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. Deathisabilit | 2015-03-13 |