MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON PS INSERT; KNEE IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding allergy/reaction and pain involving an unknown triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned for evaluation.Medical records received and evaluation: no information was received for review with the clinical consultant.Device history review could not be performed as the device lot is unknown.Complaint history review could not be performed as the device lot is unknown.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of device, operative reports, x-rays, histopathology reports, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.

Event Description

As reported: "revision of right tkr.Patient had a triathlon pressfit ps femur, tritanium tibia, ps insert and tritanium patella.I do not have catalogue and lot numbers because the original surgery was done at another hospital.Patient states and doctor confirmed (through t lymphocytes test) that the patient has a nickel allergy and experienced knee pain." no further information available.Update 07/december: spoke to rep.No further information is available due to hospital policy.

• Brand Name: UNKNOWN TRIATHLON PS INSERT
• Type of Device: KNEE 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8213035
• MDR Text Key: 131940873
• Report Number: 0002249697-2019-00016
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 32