MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_STRYKER KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_JR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)

Event Date 06/01/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This report is for incision and drainage of the patient's left knee in (b)(6) 2013.In performing follow-up for pi (2022 revision for damage to alleged screws), records were provided that show a patient history of left total knee replacement on (b)(6) 2013, subsequent incision and drainage secondary to wound disruption in (b)(6) 2013, and revision of a patellar component due to malposition with poly exchange on (b)(6) 2021.

Manufacturer Narrative

Reported event: an event regarding patient factors (wound drainage) involving an unknown knee was reported.The event was confirmed.Method & results:  device evaluation and results: not performed as product remained implanted clinician review: a review of medical records with a clinical consultant indicated "this patient underwent a total knee arthroplasty in (b)(6) 2013 and subsequently developed drainage which required another surgery in (b)(6) 2013.The patient required revision of the patella due to malposition and a poly exchange was carried out in 2021.In (b)(6) 2022 the patient pain and it was determined that one of the screws had fractured.I can confirm that the patient had a total knee arthroplasty and had a secondary surgery on the patella with the use of screws and wires since i was able to review x-rays which demonstrated these procedures.This patient has had three complications including a draining wound, malposition of the patella and subsequent fracture of hardware used in the revision of the patella.The root cause of these complications cannot be determined with certainty.Wound drainage occurs when the wound disrupts for one reason or another including dehiscence, trauma and poor host tissue or poor closure.Infection can also cause wound drainage.Causes of patella malposition are multifactorial including surgical technique, patient activity level and possible trauma causing disruption of the extensor mechanism.There was a single patella view which showed rather profound adaptive changes with subluxation of the patella.Fracture of screws used for internal fixation also has several causes including surgical technique, proper reduction of the fracture and patient factors including trauma.[.]" device history review: could not be performed as lot code information was not provided.  complaint history review: could not be performed as lot code information was not provided.  conclusion: a review of medical records with a clinical consultant indicated "this patient underwent a total knee arthroplasty in april 2013 and subsequently developed drainage which required another surgery in june 2013.The patient required revision of the patella due to malposition and a poly exchange was carried out in 2021.In september 2022 the patient pain and it was determined that one of the screws had fractured.I can confirm that the patient had a total knee arthroplasty and had a secondary surgery on the patella with the use of screws and wires since i was able to review x-rays which demonstrated these procedures.This patient has had three complications including a draining wound, malposition of the patella and subsequent fracture of hardware used in the revision of the patella.The root cause of these complications cannot be determined with certainty.Wound drainage occurs when the wound disrupts for one reason or another including dehiscence, trauma and poor host tissue or poor closure.Infection can also cause wound drainage.Causes of patella malposition are multifactorial including surgical technique, patient activity level and possible trauma causing disruption of the extensor mechanism.There was a single patella view which showed rather profound adaptive changes with subluxation of the patella.Fracture of screws used for internal fixation also has several causes including surgical technique, proper reduction of the fracture and patient factors including trauma.[.]" no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This report is for incision and drainage of the patient's left knee in (b)(6) 2013.In performing follow-up for pi (2022 revision for damage to alleged screws), records were provided that show a patient history of left total knee replacement on (b)(6) 2013, subsequent incision and drainage secondary to wound disruption in (b)(6) 2013, and revision of a patellar component due to malposition with poly exchange on (b)(6) 2021.

• Brand Name: UNKNOWN_STRYKER KNEE
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15912625
• MDR Text Key: 304787426
• Report Number: 0002249697-2022-01765
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2022
• 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?: No
• Date Manufacturer Received: 01/24/2023
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 98 KG