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 Unstable (1667)

Patient Problems Pain (1994); Injury (2348); Joint Laxity (4526)

Event Date 06/08/2020

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.

Event Description

As part of 2018-008 x3 knee 10 year multicenter iis, the following was reported: bmi 35.886; underwent left tka for osteoarthritis; revised due to pain and instability 4.1 years after index surgery.

Manufacturer Narrative

Reported event an event regarding instability involving a unknown insert was reported.The event was confirmed by medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: no clinical or pmh, no patient demographics, no exam of explanted components, no imaging studies available for review.Based upon the information available for review, the event description is confirmed, but insufficient data is presented to create a medical report for this case.-product history review: not performed as the device lot details were not provided.-complaint history review: not 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.

Event Description

As part of 2018-008 x3 knee 10 year multicenter iis, the following was reported: bmi 35.886; underwent left tka for osteoarthritis; revised due to pain and instability 4.1 years after index surgery.Update (b)(6) 2020 wg: revision operative report was provided with diagnosis "instability, left knee, status post total knee replacement." procedure is noted "synovectomy, scar removal and change of polyethylene spacer." the insert was revised to an insert which was 2mm thicker than the primary implant.

• 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
• MDR Report Key: 10188988
• MDR Text Key: 196236944
• Report Number: 0002249697-2020-01271
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 06/08/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR