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

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 01/07/2015

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.

Event Description

Patient called stating she had a right knee replacement done on (b)(6) 2015 and reported that she has been feeling pain for a few months.Patient reported that her surgeon suggested a revision surgery after mri confirmed loosening or tibia and femoral components.She also would like to know if her implants are part of a recall.Patient is not yet scheduled for a revision surgery.

Event Description

Patient called stating she had a right knee replacement done on (b)(6) 2015 and reported that she has been feeling pain for a few months.Patient reported that her surgeon suggested a revision surgery after mri confirmed loosening or tibia and femoral components.She also would like to know if her implants are part of a recall.Patient is not yet scheduled for a revision surgery.

Manufacturer Narrative

An event regarding loosening of femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: device evaluation could not be performed as no items were returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: device history review could not be performed because the device associated with this event was not returned nor was it properly identified.Complaint history review: complaint history review could not be performed because the device associated with this event was not returned nor was it properly identified.Conclusions: the event could not be confirmed nor the root cause determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopedics.If devices and/or additional information become available, this investigation will be reopened.

• Brand Name: UNKNOWN FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9221169
• MDR Text Key: 163707210
• Report Number: 0002249697-2019-03586
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 122