MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; IMPLANT

Catalog Number 0580-1-442

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/08/2015

Event Type  Injury  

Event Description

It was reported that the stem broke.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown exeter stem 44 no2.A supplemental report will be submitted upon completion of the investigation.

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).Images of the device are included in the mar."the exeter stem fractured along the neck approximately 0.8 inches from the proximal edge of the trunnion, as seen in figures 5.Detailed images of the fractured stem and laser marking are shown in figures 6 and 7.The proximal fragment and fracture surface associated with the proximal fragment are shown in figures 8 and 9, respectively.The fracture surface of the distal fragment of the exeter body can be seen in figure 10.Based on macroscopic features on the fracture surface, the region of origin and the approximate direction of fracture are illustrated.The fracture surface associated with the exeter body was analyzed using a scanning electron microscope (sem) for further evaluation." the material analysis report concluded: the exeter stem fractured at the neck due to fatigue, progressing from the lateral to the medial surface.The fracture origin was observed at or near the laser markings.The stem material was consistent with astm 1586 and iso 5832-9.The ceramic head likely fractured during or after explantation.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: insufficient information was received for review with a clinical consultant.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 investigation concluded that the exeter stem fractured at the neck due to fatigue, progressing from the lateral to the medial surface.However, no material or manufacturing defects were observed on the part features examined.Further information such as operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.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 the stem broke.

• Brand Name: EXETER V40 STEM 44MM NO 2
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK (MDR); ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4745745
• MDR Text Key: 5774336
• Report Number: 0002249697-2015-01430
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2006
• Device Catalogue Number: 0580-1-442
• Device Lot Number: GZ610632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2001
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR