MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,health professional,oth report with the FDA on 2015-04-21 for OMNIFIT MICROSTRUCTURED STEM MOLD#157 6007-1035 manufactured by Stryker Orthopaedics-mahwah.
[18291729]
Patient was simply walking and implant broke. Original stem implanted 15 years ago was revised on (b)(6) 2015 (along with head and liner implanted in 2012). The cup implanted in 2012 remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
[18646849]
When completed, the evaluation summary will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[39856544]
An event regarding fracture involving an omnifit stem was reported. The event was confirmed. Method and results: device evaluation and results: the femoral stem trunnion fractured in fatigue with the origin on the lateral side. An intergranular corrosion process was apparent within the stem trunnion at the taper interfaces. The associated grain boundary separation and cracking likely resulted in the observed fatigue fracture. The stem material was consistent with the astm f75 cocomo casting alloy. No material or manufacturing defects were observed on the part features examined. Medical records received and evaluation: if the (b)(6) 2015 revision was the second revision, it is possible damage to the lateral trunnion at the first revision in which the stem was retained may have resulted in an initiation site for the subsequent fatigue fracture in this patient. There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation. Device history review: there were no reported discrepancies. Complaint history review: there have been no other events for the referenced lot. Conclusions: the investigation concluded that stem fractured in fatigue. Review of the provided information by a consulting clinician indicated that damage to the lateral trunnion retained by the stem during the first revision may have resulted in an initiation site for fatigue fracture. There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.
Patient Sequence No: 1, Text Type: N, H10
[39856585]
Patient was simply walking and implant broke. Original stem implanted 15 years ago was revised on (b)(6) 2015 (along with head and liner implanted in 2012). The cup implanted in 2012 remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2015-01294 |
| MDR Report Key | 4712713 |
| Report Source | 00,05,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-04-21 |
| Date of Report | 2015-03-26 |
| Date of Event | 2015-03-25 |
| Date Mfgr Received | 2016-02-08 |
| Date Added to Maude | 2015-04-21 |
| 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 | MR. KEYLA NAVEDO |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIFIT MICROSTRUCTURED STEM MOLD#157 |
| Generic Name | IMPLANT |
| Product Code | LDH |
| Date Received | 2015-04-21 |
| Returned To Mfg | 2015-04-17 |
| Catalog Number | 6007-1035 |
| Lot Number | S96T286 |
| 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 | 2015-04-21 |