MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #2 LM/RL; IMPLANT

Catalog Number 5620-B-201

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 05/26/2015

Event Type  Injury  

Event Description

Mrs.(b)(6), from a (b)(6), reported the following event: "a patient contacted the center because he developed an allergy to the knee prosthesis.".

Manufacturer Narrative

An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested, but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding an allergic reaction to the implanted device was reported.The event was not confirmed.Device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no patient medical records were provided for review.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events for this lot id.The exact cause of the event could not be determined because no patient medical records were provided for review.No further investigation for this event is possible at this time.If devices and/or additional information become available, this investigation will be reopened.

Event Description

Mrs.(b)(6)from a (b)(6) center in (b)(6) , reported the following event: "a patient contacted the center because he developed an allergy to the knee prosthesis.".

• Brand Name: TRIATHLON PKR BASEPLATE #2 LM/RL
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4896038
• MDR Text Key: 6835313
• Report Number: 0002249697-2015-02223
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082567
• 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,Followup
• Report Date: 06/10/2015

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: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 5620-B-201
• Device Lot Number: HBVMA
• Other Device ID Number: STERILE LOT# MSHLL06A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2012
• 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