MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TI DUR REG FLUTED STEM 23X80MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	64786665
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
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Loosening of the mrh prosthesis in the femoral area.Stem loosened from femur.
Additional Manufacturer Narrative
An event regarding disassociation and loosening involving a duracon stem component was reported.The event was confirmed by medical review.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 21-may-2019.This inspection indicated that damage consistent with scratching was observed on the articulating surface of the femoral component.Damage on the threads of the 23mm x 80mm fluted stem is consistent with contact against a hard object.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 was 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 mar report indicates that damage consistent with scratching was observed on the articulating surface of the femoral component.Damage on the threads of the 23mm x 80mm fluted stem is consistent with contact against a hard object.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.Yellow 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.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.
Event or Problem Description
Loosening of the mrh prosthesis in the femoral area.Stem loosened from femur.

• Brand Name: TI DUR REG FLUTED STEM 23X80MM
• 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: 8514605
• Report Number: 0002249697-2019-01597
• Device Sequence Number: 1315438
• Product Code: JWH
• UDI-Device Identifier: 07613327044973
• UDI-Public: 07613327044973
• 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): 06/17/2019

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: 09/30/2018
• Device Catalogue Number: 64786665
• Device Lot Number: T3089
• 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: 06/17/2019
• 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