MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #7R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515F702

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Anxiety (2328); Reaction (2414); Sleep Dysfunction (2517)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient called stating he was not feeling well since his right knee surgery.Has seen several doctors of which his bloodwork revealed cobalt & nickel levels are present.He stated fatigued, insomnia, nerves since the surgery but the knee is fine.Stated he would like a call back with answers if the surgery is the reason he is not feeling well.

Manufacturer Narrative

Concomitant medical products: triathlon symmetric x3 patella, cat# 5550-g-360, lot# x3ky; triathlon ps x3 tibial insert, cat# 5532-g-611, lot# mlaaet; triathlon prim tib baseplate - cemented, cat# 5520-b-600, lot# hlvld; simplex p full dose 1 pack, cat# 6191-1-001, lot# rks167; simplex p full dose 1 pack, cat# 6191-1-001, lot# rks167.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event related to alleged "patient factors" involving a triathlon femoral component was reported.The event was not confirmed.Method and results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a review of the medical records by the consulting clinician indicated "no patient demographics and no clinical documentation or follow-up is available, and there is no indication of relevance of the melissa test to either implant components or patient¿s non-specific symptoms.There is no documented relationship between the symptoms described and the apparently asymptomatic right total knee arthroplasty components implanted in this case." -device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the event was not confirmed nor the root cause could not be determined as per the review of the medical records by the consulting clinician indicated "no patient demographics and no clinical documentation or follow-up is available, and there is no indication of relevance of the melissa test to either implant components or patient¿s non-specific symptoms.There is no documented relationship between the symptoms described and the apparently asymptomatic right total knee arthroplasty components implanted in this case." if further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient called stating he not feeling well since his right knee surgery.Has seen several doctors of which his bloodwork revealed cobalt and nickel levels are present.He stated fatigued, insomnia, nerves since the surgery but the knee is fine.Stated he would like a call back with answers if the surgery is the reason he is not feeling well.

• Brand Name: TRIATHLON PS FEM COMP #7R-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NJ NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6176833
• MDR Text Key: 62474541
• Report Number: 0002249697-2016-03928
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 5515F702
• Device Lot Number: S8S4T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2012
• 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
• Patient Age: 67 YR