MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIOFLEX TOTAL KNEE PS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number 72-15-0510

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

A scorpio tkr required a change of poly liner for poly wear.The original component was implanted (b)(6) 2005.In the process of changing the poly liner, the series 7000 cemented baseplate was also found to be loose.It came out with no cement adhering to it, although the cement bone interface was intact.The surgeon requested no tibias or femurs be sent.As there was no replacement tibia on hand, the existing tibia was re-cemented in place.A new 12mm ps poly was implanted, and the patella was resurfaced using a sz 5 scorpio patella.Only the insert is available for return.The tibia was re implanted.There are no other notes etc available.The x-ray was taken (b)(6) 2019.

Event Description

A scorpio tkr required a change of poly liner for poly wear.The original component was implanted on (b)(6) 2005.In the process of changing the poly liner, the series 7000 cemented baseplate was also found to be loose.It came out with no cement adhering to it, although the cement bone interface was intact.The surgeon requested no tibias or femurs be sent.As there was no replacement tibia on hand, the existing tibia was re-cemented in place.A new 12mm ps poly was implanted, and the patella was resurfaced using a sz 5 scorpio patella.Only the insert is available for return.The tibia was re implanted.There are no other notes etc available.The x-ray was taken on (b)(6) 2019.

Manufacturer Narrative

An event regarding wear involving a scorpio insert was reported.The event was confirmed based on evaluation of the returned device.Method & results: product evaluation and results: inspection of the returned device noted the following: damage consistent with the explantation process was observed on the anterior surface of the implant.Burnishing, scratching, delamination, and third body indentations were observed on the articulating surface and post; which are common damage modes of uhmwpe.The aforementioned damage modes are consistent with contact against the femoral component.Yellow discoloration consistent with the absorption of synovial fluid was also observed.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components (baseplate).Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: inspection of the returned device noted the following: damage consistent with the explantation process was observed on the anterior surface of the implant.Burnishing, scratching, delamination, and third body indentations were observed on the articulating surface and post; which are common damage modes of uhmwpe.The aforementioned damage modes are consistent with contact against the femoral component.Yellow discoloration consistent with the absorption of synovial fluid was also observed.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components (baseplate) 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.

• Brand Name: SCORPIOFLEX TOTAL KNEE PS
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8964497
• MDR Text Key: 156579066
• Report Number: 0002249697-2019-03081
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07613154020157
• UDI-Public: 07613154020157
• Combination Product (y/n): N
• PMA/PMN Number: K041591
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Model Number: 72-15-0510
• Device Catalogue Number: 72-15-0510
• Device Lot Number: 12492201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 68