MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_CORK_PRODUCT; IMPLANT

Catalog Number UNK_SHC

Device Problem Metal Shedding Debris (1804)

Patient Problems Necrosis (1971); Complaint, Ill-Defined (2331)

Event Date 01/18/2015

Event Type  Injury  

Event Description

The surgeon reported that he carried out a revision hip case for a trident/exeter and that he suspects trunnionosis.There were no signs of the this prior to surgery, however upon accessing the hip, the customer reported that he found muscle necrosis, and post op tests have shown high levels of metal.The customer has reported that he had undertaken a planned cement revision approximately 2.5 weeks ago and that time he was not expecting to find any muscle wastage.The patient will undergo a further procedure on (b)(6) 2015.

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.Explanted devices were discarded by customer.

Manufacturer Narrative

An event regarding altr (trunnionosis, muscle necrosis, elevated blood metal levels) involving an exeter stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed, device was not returned.-medical records received and evaluation: insufficient medical records were received for review however a review of altr by a clinical consultant indicated proper analysis of reported cases with minimal information regarding potentially elevated blood metal ions requires adequate diagnostic studies to provide a balanced perspective of the case.-device history review: could not be performed as the device was not properly identified.-complaint history review: could not be performed as the device was not properly identified.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of the device, pre- and post-operative x-rays, operative reports, pathology reports, as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

The surgeon reported that he carried out a revision hip case for a trident/exeter and that he suspects trunnionosis.There were no signs of the this prior to surgery, however upon accessing the hip the customer reported that he found muscle necrosis, and post op tests have shown high levels of metal.The customer has reported that he had undertaken a planned cement revision approximately 2.5 weeks ago and that time he was not expecting to find any muscle wastage.The patient will undergo a further procedure on (b)(6) 2015.

• Brand Name: UNKNOWN_CORK_PRODUCT
• 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: 4576921
• MDR Text Key: 15963835
• Report Number: 0002249697-2015-00609
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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