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

Catalog Number	7115-0009
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional 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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Revised for loosening of tibial tray.
Additional Manufacturer Narrative
An event regarding loosening involving a scorpio baseplate was reported.The event was not confirmed; however subsidence was confirmed through a review of the case by a clinician.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation:a review of the provided medical records by a clinical consultant indicated: unable to confirm event; tibial component has subsided and in varus; additional records such as operative reports are needed.-device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Revised for loosening of tibial tray.

• 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: 7912123
• Report Number: 0002249697-2018-03100
• Device Sequence Number: 1937315
• Product Code: JWH
• UDI-Device Identifier: 07613327033373
• UDI-Public: 07613327033373
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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: 04/30/2013
• Device Catalogue Number: 7115-0009
• Device Lot Number: 3WWMEE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: 55 YR
• Patient Weight: 114