MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER 2.5 I M PLUG 14MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 09390114

Device Problems Break (1069); Fracture (1260); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by stryker sales rep that surgeon was performing a hemi hip replacement for a fractured neck femur using exeter trauma stem - ets.It was further reported that when the surgeon tried to take the introducer out it got stuck and the plug would not dislodge from the introducer.It was reported that the plug broke.

Manufacturer Narrative

An event regarding a fractured device involving an exeter bone plug was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis determined that the exeter plug fractured in overload.The fracture initiated along the outer surface and propagated inward.No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical records were provided.-device history review: dhr review was satisfactory.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: material analysis determined that the exeter plug fractured in overload.The fracture initiated along the outer surface and propagated inward.No material or manufacturing defects were observed on the surfaces examined.A capa trend analysis was conducted for the reported failure mode and concluded that fracture of exeter bone plugs may result from factors such as errors made during use or design factors.No further investigation for this event is possible at this time.

Event Description

It was reported by stryker sales rep that surgeon was performing a hemi hip replacement for a fractured neck femur using exeter trauma stem - ets.It was further reported that when the surgeon tried to take the introducer out it got stuck and the plug would not dislodge from the introducer.It was reported that the plug broke.

• Brand Name: EXETER 2.5 I M PLUG 14MM
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5036072
• MDR Text Key: 25131533
• Report Number: 0002249697-2015-02819
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K980843
• 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: 07/31/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 09390114
• Device Lot Number: L8271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 82 YR