MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 18X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	64786640
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to loosening involving a stem extender component was reported.The event was not confirmed.Method & results product evaluation and results: product not returned.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 lot referenced.Conclusions: 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.
Event or Problem Description
Loosening of the mrh prosthesis in the femoral area.Stem loosened from femur.
Event or Problem Description
Loosening of the mrh prosthesis in the femoral area.Stem loosened from femur.
Additional Manufacturer Narrative
An event regarding revision due to loosening involving a duracon stem component was reported.The event was not confirmed.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report (mar).This inspection indicated that the tibial baseplate and 18mm x 80mm fluted stem were returned in the assembled condition.Bone cement was observed on the distal surface of the femoral component.Energy dispersive spectroscopy (eds) analysis was performed on the 18mm x 80mm fluted post.Eds showed that the reported component is consistent with its respective drawing.Dimensional and inspection were not performed as the product was returned damaged.Damage of the internal hex on both the 23mm x 80mm and the 18mm x 80mm fluted stems is consistent with implantation damage.Damage present on the articulating surface is consistent with burnishing, scratching, and third body indentations.Eds showed that each component is consistent with its respective drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surface examined.Clinician review: a review of the provided medical record deemed insufficient by a clinical consultant indicated: provided x-rays confirm disassociation.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.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 lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays 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: TI DUR REG FLUTED STEM 18X80MM
• 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: 8515273
• Report Number: 0002249697-2019-01600
• Device Sequence Number: 1767637
• Product Code: JWH
• UDI-Device Identifier: 07613327044935
• UDI-Public: 07613327044935
• Combination Product (Y/N): N
• PMA/510(K) Number: K973164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 10/31/2021
• Device Catalogue Number: 64786640
• Device Lot Number: 0050318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 06/18/2019
• 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 Weight: 75