MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CROSSFIRE ECCENTRIC INSERT 20; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number S-2302C-3250

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Joint Dislocation (2374)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

Catalog number unknown at this time.Device description reported as an unknown liner.When completed, the investigation results will be submitted in a supplemental report.

Event Description

It was reported that there was a revision of a primary total hip with omnifit implants and series ii liners.The acetabular liner fractured causing the patient to dislocate.Surgeon removed the liner and head and tried to implant a constrained liner.

Manufacturer Narrative

An event regarding crack/fracture of an omnifit liner was reported.The event was confirmed.Method & results: -device evaluation and results: the material analysis report concluded that, "a fragment of the distal rim fractured from the insert.The fragment broke in fatigue.Damage was observed on the femoral head and insert.The damage observed on the femoral head was consistent with the head articulating against the rim of the insert after the insert broke.No materials or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: not performed as medical records were not provided for review.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the investigation concluded that the edge loading on the rim of the omnifit liner resulted in the fracture of the liner.However, the root cause could not be determined.Further information such as progress notes and patient history is needed to complete the investigation for determining the root cause.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.

Event Description

It was reported that there was a revision of a primary total hip with omnifit implants and series ii liners.The acetabular liner fractured causing the patient to dislocate.Surgeon removed the liner and head and tried to implant a constrained liner.

• Brand Name: CROSSFIRE ECCENTRIC INSERT 20
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5130093
• MDR Text Key: 27563070
• Report Number: 0002249697-2015-03272
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

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: 07/31/2012
• Device Catalogue Number: S-2302C-3250
• Device Lot Number: 12LFC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2007
• Is the Device Single Use?: No
• 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: 92 YR