MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO SIZE 5 CR INSERT 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 72-12-0508

Device Problem Degraded (1153)

Patient Problem Pain (1994)

Event Date 06/16/2022

Event Type  Injury  

Event Description

Patient admitted with knee pain for a scope and aspirate of knee joint.When clearing up the knee, the surgeon noticed a deficit in the poly on the posterior medial portion.He could see the rim of the baseplate so knew it was delaminated/sheared in his words.

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.Device not returned.

Event Description

Patient admitted with knee pain for a scope and aspirate of knee joint.When clearing up the knee, the surgeon noticed a deficit in the poly on the posterior medial portion.He could see the rim of the baseplate so knew it was delaminated/sheared in his words.

Manufacturer Narrative

Reported event: an event regarding wear involving a scorpio insert was reported.The event was via evaluation of the provided photographs.Method & results: -device evaluation and results: no product was returned for evaluation however, photographs were provided for review.The photographs show a recently explanted insert, wear/delamination is visible on one of the condyles of the insert.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced, conclusion: the event was confirmed through review of the provided photographs.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO SIZE 5 CR INSERT 8MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14982978
• MDR Text Key: 295679462
• Report Number: 0002249697-2022-00994
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07613327044331
• UDI-Public: 07613327044331
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 72-12-0508
• Device Catalogue Number: 72120508
• Device Lot Number: LFC800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female