MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER. FEMORAL STEM + 2 PMMA; IMPLANT

Catalog Number 05800444

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/29/2015

Event Type  Injury  

Event Description

It was reported that exeter stem implanted in 1998 has broken mid-way down the prosthesis and requires revision.

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown exeter stem.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material analysis report (mar).The parts were examined with the aid of a stereo microscope at magnifications up to 50x.The medial side of the hip stem in the region of the fracture exhibited fretting, figure 8 shows the distal portion of the stem showing that region.The stem fragmented during fracture with two notable fragments missing.The report concluded: the exeter stem fractured at approximately 3 ½ inches from the distal tip of the device.The fracture progressed through fatigue.No further information could be ascertained due to post fracture abrasion of the broken parts.(b)(4).No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated that the principal root cause of failure was an overload condition as caused by both cup malposition and a bone defect condition in the upper lateral femoral stem section causing fatigue build-up due to loss of bone support around the exeter stem.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the root cause of the event was an overload condition as caused by both cup malposition and a bone defect condition in the upper lateral femoral stem section causing fatigue fracture due to loss of bone support around the exeter stem.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that exeter stem implanted in 1998 has broken mid-way down the prosthesis and requires revision.

• Brand Name: EXETER. FEMORAL STEM + 2 PMMA
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4551011
• MDR Text Key: 5517101
• Report Number: 0002249697-2015-00450
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2002
• Device Catalogue Number: 05800444
• Device Lot Number: GV278131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/1997
• 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