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

Catalog Number 623-00-40G

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erythema (1840); Pain (1994); Injury (2348)

Event Date 11/10/2010

Event Type  Injury  

Event Description

Approximately 3 months after the primary surgery the patient was still experiencing pain and redness.The hip still gets extremely red intermittently.The patient is in constant pain.He feels worse now than before the surgery.He can no longer ride his bike or golf and daily activities are limited.A second opinion doctor recommended injections first and then a possible revision surgery.After the injections did not help, the doctor declined to pursue treating this patient or a revision surgery.

Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat.No.: 540-11-58g; trident psl ha solid back 58mm; lot code: 33147001.Cat.No.: 6052-1035s; secur-fit max 127 hip stem #10; lot code: mjpm6v.Cat.No.: 6519-1-040; delta un.Fem hd 40mm r40 16/18; lot code: 34727701.Cat.No.: 19-0000t; uni adaptor sleeve c taper ti; lot code: 34227203.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.H3 other text : currently implanted.

Manufacturer Narrative

An event regarding pain involving a trident liner was reported.The event was not confirmed.Method and results: device evaluation could not be performed as no items were returned.Medical records received and evaluation: a medical review was performed and concluded: "there is no evidence that this patient¿s persistent trochanteric bursitis was related to factors of faulty design, manufacturing or materials of his non-recalled hip arthroplasty components." device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicated there have been no other similar events for the reported lot.Conclusion; the exact cause of the event could not be determined however a medical review concluded that there was no evidence of a device related issue.This device is not under the scope of the a product recall.No further investigation is required at this time.If further information and/or device become available, this investigation will be re-opened.Product surveillance will continue to monitor for trends.A capa trend analysis was conducted for the reported failure mode and concluded pain may result from other factors not necessarily related to the device.

Event Description

Approximately 3 months after the primary surgery the patient was still experiencing pain and redness.The hip still gets extremely red intermittently.The patient is in constant pain.He feels worse now than before the surgery.He can no longer ride his bike or golf and daily activities are limited.A second opinion doctor recommended injections first and then a possible revision surgery.After the injections did not help, the doctor declined to pursue treating this patient or a revision surgery.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4813067
• MDR Text Key: 20366414
• Report Number: 0002249697-2015-01778
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2015

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 Expiration Date: 06/30/2015
• Device Catalogue Number: 623-00-40G
• Device Lot Number: MJJLN0
• Other Device ID Number: STERILE LOT# MSGJK01A4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2010
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 118