MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 24MM XS/S S1/S2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64813224

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: mrh knee fem s lft; cat# 6481-1-110; lot# ste4y.Mrh tibial b/plt keel sml 2; cat# 6481-3-111; lot# eh9ch.Mrhk fem distal blk 10mm s; cat# 6481-1-210; lot# std6s.Triathlon press-fit stem 24mm x 150mm; cat# 5566-s-024; lot# m8w46d.Mrh tib rot comp xs-xl; cat# 6481-2-100; lot# 068930.Mrhk femoral bushing; cat# 6481-2-110; lot# ldt571.Tri press-fit stem 18x150mm; cat# 5566-s-018; lot# m9l41d.Mrhk bumper insert 3 degrees; cat# 6481-2-133; lot# lds932.Mrhk femoral bushing; cat# 6481-2-110; lot# lcn996.Mrh axle; cat# 6481-2-120; lot# ctd5535.Mrhk tibial sleeve; cat# 6481-2-140; lot# ldy969.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

On (b)(6) 2014 dr.(b)(6) revised the patient with a hinge prosthesis.The patient developed pji, and is now revised with all components exchanged.

Manufacturer Narrative

An event regarding infection involving an mrh insert was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as items were not returned.Medical records received and evaluation: not performed as medical records were not received.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there has been no other similar event for the reported lot and sterile lot.Conclusions: revision surgery took place due to infection whereby the reported devices were explanted.The exact cause of the event could not be determined as insufficient information was provided for this investigation.Further information such as further patient details, medical records, x-rays, operative reports and pathology reports detailing the reported infection are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded infection is a known possible adverse outcome of surgery and is beyond stryker's control.

Event Description

On (b)(6) 2014 dr.(b)(6) revised the patient with a hinge prosthesis.The patient developed pji, and is now revised with all components exchanged.

• Brand Name: MRHK TIB INS 24MM XS/S S1/S2
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5770079
• MDR Text Key: 48791875
• Report Number: 0002249697-2016-02186
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 64813224
• Device Lot Number: LDW218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2014
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 118