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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	10/26/2016
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device not returned.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to failed tibial component, right total knee replacement.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to failed tibial component, right total knee replacement.
Additional Manufacturer Narrative
An event regarding loosening involving a scorpio baseplate was reported.The event was confirmed by review of the medical records by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: a series 7000 tibial baseplate failed due to mechanical loosening within 5-years in a patient with extreme morbid obesity.Given the context of the information, issues with suboptimal cementation or component malposition are suspected to have contributed to failure although this cannot be absolutely proven due to absence of x-ray information.Morbid obesity represents an important secondary failure contributing factor while the role of two reported traumatic incidents to the knee remains unclear, also depending upon availability of x-rays for more detailed evaluation over time.Does the review identify any procedural related factors that contributed to the event? suspected although currently unproven issues with suboptimal cementation technique component malposition cannot be excluded as relevant factor until proof of country from x-ray information.Does the review identify any patient related factors that contributed to the event? extreme morbid obesity (bmi=49) as secondary factor to increase overload.Two traumatic incidents to the knee at 1-year post primary cannot be excluded from playing a role until proof of contrary from x-rays.Does the review identify any device related factors that caused or contributed to the adverse event? no device-related factors are associated with any of the implanted devices.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: although the event was confirmed, the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays 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.

• 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: 8878691
• Report Number: 0002249697-2019-02780
• Device Sequence Number: 253833
• Product Code: JWH
• UDI-Device Identifier: 07613327033373
• UDI-Public: 07613327033373
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 08/31/2016
• Device Catalogue Number: 7115-0009
• Device Lot Number: MKLVDP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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: 66 YR