MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT MICRO-STRUCTURED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 1007-0625

Device Problems Corroded (1131); Fracture (1260); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Information (3190)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Revision of the right hip due to failed hardware.Sales rep was contacted on 4-apr-2016 with a picture of a securfit stem with fractured neck.The surgeon removed the stem and replaced with competitor.There was no surgical delay and the procedure was successfull.

Manufacturer Narrative

Reported event: an event regarding corrosion & fracture of an omnifit stem was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis indicated: "corrosion was observed between the head taper and stem trunnion of the omnifit stem.The base alloy of the stem was consistent with an astm f75 alloy.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: review of medical records by a consulting clinician indicated: "other than the device corrosion and fatigue fracture the completed material analysis reviewed found no other material or manufacturing defects.Device history review: indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no others events for the lot referenced.Conclusions: a material analysis concluded: "corrosion was observed between the head taper and stem trunnion of the omnifit stem.The base alloy of the stem was consistent with an astm f75 alloy.No material or manufacturing defects were observed on the surfaces examined." it was also noted that the "the origin of the fracture occurred in the region of corrosion and progressed through fatigue and final fracture." if additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

Revision of the right hip due to failed hardware.Sales rep was contacted on (b)(6) 2016 with a picture of a securfit stem with fractured neck.The surgeon removed the stem and replaced with competitor.There was no surgical delay and the procedure was successfull.

• Brand Name: OMNIFIT MICRO-STRUCTURED STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5620978
• MDR Text Key: 44116693
• Report Number: 0002249697-2016-01454
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K844817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/1992
• Device Catalogue Number: 1007-0625
• Device Lot Number: 7C240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/1987
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR