MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-36G

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033); Reaction (2414)

Event Date 06/23/2003

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device remains implanted.

Event Description

The patient reported experiencing pain, squeaking, popping, rashes, aches all over the body and erectile dysfunction.Right hip was not cemented.

Manufacturer Narrative

An event regarding pain, audible noise and allergy/reaction involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the device was not returned for analysis.- medical review: a review by a medical consultant noted: there is no confirmation of the complaints noted in the event description and no x-ray evidence of pathology in either hip as of (b)(6) 2015.Information from stryker orthopaedics indicates this patient¿s hip implants are not a subject of a recall.There is no evidence of faulty component design, manufacturing or materials being responsible for these event descriptions.-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: a review by a clinical consultant concluded that "there is no confirmation of the complaints noted in the event description and no x-ray evidence of pathology in either hip as of (b)(6) 2015.Information from stryker orthopaedics indicates this patient¿s hip implants are not a subject of a recall.There is no evidence of faulty component design, manufacturing or materials being responsible for these event descriptions.'' no further investigation is required at this time.If device and/or additional information is received this investigation will be reopened.

Event Description

The patient reported experiencing pain, squeaking, popping, rashes, aches all over the body and erectile dysfunction.Right hip was not cemented.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5001601
• MDR Text Key: 22903322
• Report Number: 0002249697-2015-02613
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 05/12/2017

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: Lay User/Patient
• Device Expiration Date: 05/31/2008
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: U5612802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2003
• 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