MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT CONSTRAINED INSERT; IMPLANT

Catalog Number 690-10-28G

Device Problems Off-Label Use (1494); Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Swelling (2091); Injury (2348); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/21/2015

Event Type  Injury  

Event Description

Patient's left hip was revised due to pain, pseudo tumor and range of motion.Surgeon swapped constrained liner only as patient had a depuy femoral head and stem implanted.

Manufacturer Narrative

It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding off label use involving a trident insert was reported.Conclusion: a stryker liner and competitor head were revised.The ifu provides instructions, warnings and precautions of the capability products that can be used.Based on the provided information it has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient's left hip was revised due to pain, pseudo tumor and range of motion.Surgeon swapped constrained liner only as patient had a depuy femoral head and stem implanted.

• Brand Name: TRIDENT CONSTRAINED INSERT
• 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: 4777388
• MDR Text Key: 5780896
• Report Number: 0002249697-2015-01582
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 690-10-28G
• Device Lot Number: 28164901
• Other Device ID Number: STER. LOT 0504N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2005
• 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; Required Intervention
• Patient Age: 56 YR