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

Catalog Number 72-3-1108

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was destroyed on explantation and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported that surgeon revised patient's right knee poly for an unknown reason.Surgeon removed scar tissue and swapped poly - all other compoinents remained and were well fixed.

Manufacturer Narrative

An event regarding the left knee revision for an unknown reason involving a scorpio insert was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.Medical records received and evaluation: the provided medical information was submitted for review and the clinical consultant concluded that "after fourteen years in situ, the poly inserts of both total knee arthroplasties were replaced by the same size components.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this late clinical situation." device history review: review of the device history records indicates all devices accepted into final stock met specifications.Complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause of the reported arthrofibrosis determined due to the minimal information received.Further information such as clinical or past medical history, operative reports, returned devices or examination of explanted components, or dated serial x-rays are needed to complete the investigation for determining root cause.After fourteen years in situ, the poly inserts of both total knee arthroplasties were replaced by the same size components.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this late clinical situation.A capa trend analysis was conducted for the reported failure mode and concluded arthrofibrosis may result from other factors not necessarily related to the device.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

It was reported that surgeon revised patient's right knee poly for an unknown reason.Surgeon removed scar tissue and swapped poly - all other compoinents remained and were well fixed.

• Brand Name: SCORPIO PS TIB INSERT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5239316
• MDR Text Key: 31719729
• Report Number: 0002249697-2015-03959
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2015

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 Expiration Date: 10/31/2004
• Device Catalogue Number: 72-3-1108
• Device Lot Number: 45581701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/1999
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 90