MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JR PATELLOFEMORAL COMPONENT SIZE 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

Revision surgery to remove restoris uni knee right side.A corin total knee was implanted following removal of uni implant.Patient complained of pain post primary uni compartment surgery.

Event Description

Revision surgery to remove restoris uni knee right side.A corin total knee was implanted following removal of uni implant.Patient complained of pain post primary uni compartment surgery.

Manufacturer Narrative

Reported event: an event regarding pain involving an unknown femoral component 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 information by a clinical consultant indicated: pi which is from (b)(6) and represents a male patient, dob on (b)(6) 1958 whose date of implantation is listed as on (b)(6) 2016 and explantation on (b)(6) 2020.The event description states: "revision surgery to remove restoris uni knee right side.Patient complained of pain.A corin total knee was implanted." undated x-ray: lateral of knee demonstrating patella-femoral arthroplasty with no gross pathology.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.Based upon the single x-ray provided, neither confirmation of the event description nor preparation of a medical report is possible for this case.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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text: device not available.

• Brand Name: UNKNOWN_JR PATELLOFEMORAL COMPONENT SIZE 4
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10808472
• MDR Text Key: 215266516
• Report Number: 0002249697-2020-02377
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR