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

Catalog Number	7115-0009
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	05/30/2018
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 hav been no other events for the reported lot.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.Not available.
Event or Problem Description
It was reported that patient's left knee was revised due to tibial component loosening.Patient was revised to a triathlon ts knee.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: SERIES 7000 STANDARD TIBIA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7641303
• Report Number: 0002249697-2018-01973
• Device Sequence Number: 2413195
• Product Code: JWH
• UDI-Device Identifier: 07613327033373
• UDI-Public: 07613327033373
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 07/01/2008
• Device Catalogue Number: 7115-0009
• Device Lot Number: T03L616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/27/2018
• 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: 59 YR
• Patient Weight: 99