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

Catalog Number UNK_JR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 11/06/2023

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.H3 other text : device not returned.

Event Description

Patient reported continued swelling after revision.

Manufacturer Narrative

Reported event: an event regarding pain/swelling involving an unknown knee was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless cruciate retaining total knee arthroplasty who did well initially but after a fall and developed pain and stiffness and decreased range of motion necessitating a manipulation which caused further pain and symptoms.I can confirm that the patient had a total knee arthroplasty since i was able to review x-rays showing a postoperative right cementless cruciate retaining total knee arthroplasty.Documentation.The patient also, reportedly underwent revision surgery, but there is no documentation for that, so i cannot confirm that a revision was carried out.The causes of stiffness following total knee arthroplasty whether traumatic or nontraumatic are multifactorial including the magnitude of trauma, the damage to the supporting soft tissues of the knee, as well as surgical technique that would include positioning, fixation, ligament balancing and kinematics and satisfactory patella tracking.Regional complex pain syndrome can also be considered (rsd).The causes of pain and clicking following this type of surgery are also multifactorial including similarly, surgical technique, positioning and fixation of the implants, restoration of ligament stability and kinematics as well as restoration of satisfactory patella tracking and rsd as well.Since i have no supporting documentation regarding revision surgery the root cause cannot be determined if indeed, the revision occurred.The x-ray reading provided by a physician assistant is not satisfactory to determine whether or not the implant is in satisfactory position, alignment, and whether or not, it is satisfactorily fixed.Further documentation, including the reason for the revision, the revision operation report and recent preoperative and subsequent postoperative revision x-rays should be provided." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient continues to experience swelling post-implantation.A review of the medical records by a clinical consultant was unable to confirm the event as insufficient documentation related to the reported revision and thereafter was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient reported continued swelling after revision.

• Brand Name: UNKNOWN_RIGHT 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: 18468312
• MDR Text Key: 332375267
• Report Number: 0002249697-2024-00046
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/30/2024
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 63 KG