MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES 7000 STANDARD TIBIA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	7115-0011
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a scorpio baseplate was reported.The event was not confirmed.Method & results: device evaluation: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.  complaint history review: there have been no other events for the reported lot id.Conclusions: it was reported that there was a revision of knee due to loosening.The exact cause of the event could not be determined because further information such as x - ray and other medical records are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "dr.Performed a right knee revision due to loosening." a senes 7000 tibial component, scorpio-flex tibial insert, and cr femoral component were revised.There are no allegations against the liner, and the femoral component was revised to convert to a different knee system.Spoke to rep: confirmed that no further information would be released by the hospital or surgeon.

• Brand Name: SERIES 7000 STANDARD TIBIA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11523072
• Report Number: 0002249697-2021-00492
• Device Sequence Number: 4497716
• Product Code: JWH
• UDI-Device Identifier: 07613327033380
• UDI-Public: 07613327033380
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2008
• Device Model Number: 7115-0011
• Device Catalogue Number: 7115-0011
• Device Lot Number: T03N753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR