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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM IMPLANT Back to Search Results
Catalog Number 623-00-40F
Device Problems Sticking; Insufficient Information
Event Date 08/19/2015
Event Type  Injury  
Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat. No. : 6260-9-240 v40 cocr lfit head 40mm/+4, mketl9; cat. No. : 6276-4-219 19mm calcar body/bolt (+20) component level 9002-0-5721, lot code: t55345hc; cat. No. : 509-02-60f tritanium revision acetabular, lot code: mkh398; cat. No. : 2080-0030 gap plate screws, lot code: mkea8v; cat. No. : 2080-0045 gap plate screws, lot code: mkd3r6; cat. No. : 2080-0050 gap plate screws, lot code: mjrvx1; cat. No. : 2080-0055 gap plate screws, lot code: mjnatn. At this time, it cannot be determined if these devices may have caused or contributed to the patient's experience. Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation. Not returned to manufacturer.

 
Event Description

It was reported that patient presented to office in pain and diagnosed with a possible infection. During surgery, massive amounts of pus was evacuated, confirming diagnosis. Decision was made to extract all implants, but the stem was well fixed and the surgeon felt he would fracture the femur if he used anymore force to extract it. The patient was irrigated and closed as a girdle stone.

 
Manufacturer Narrative

An event regarding infection involving a trident liner was reported. The event was not confirmed. Method & results: -device evaluation could not be performed as the subject device was not returned. -medical records received and evaluation: no medical records were received for review with a clinical consultant. -device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies. -complaint history review: there have no other events found for the lot referenced and the sterile lot. Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of bloodwork for infection were not provided. A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.

 
Event Description

It was reported that patient presented to office in pain and diagnosed with a possible infection. During surgery, massive amounts of pus was evacuated, confirming diagnosis. Decision was made to extract all implants, but the stem was well fixed and the surgeon felt he would fracture the femur if he used anymore force to extract it. The patient was irrigated and closed as a girdle stone.

 
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Brand NameTRIDENT 0 DEG INSERT 40MM
Type of DeviceIMPLANT
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 Key5080414
Report Number0002249697-2015-03028
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2016
Device Catalogue Number623-00-40F
Device LOT NumberMKJ2VP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/16/2015 Patient Sequence Number: 1
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