MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM M RGT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64811121

Device Problem Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 03/18/2019

Event Type  Injury  

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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Loosening of the mrh prosthesis in the femoral area.Stem loosened from femur.

Manufacturer Narrative

An event regarding disassociation and loosening involving a mrh femoral component was reported.The disassociation between the femoral component and the stem was confirmed by medical review but the event of loosening of the femoral component was not confirmed.Method & results product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 21-may-2019.The returned device were examined with the aid of a stereomicroscope at magnifications up to 50x.This inspection indicated that the femoral component were returned in the assembled condition.Bone cement was observed on the proximal surface of the femoral component.Scratching was observed on the articulating surface of the femoral component.The threaded portion of the femoral component was inspected and noticed that debris on the internal thread; this debris was collected on an sem stub for further analysis.Energy dispersive spectroscopy (eds) analysis was performed on the femoral component and debris from femoral component.Eds showed that the femoral component is consistent with its respective drawing.The elemental constitute of the debris from femoral component is ca-p-s which is consistent with biological material.Dimensional and inspection were not performed as the product was returned damaged.Damage consistent with scratching was observed on the articulating surface of the femoral component.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 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.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 Description

Loosening of the mrh prosthesis in the femoral area.Stem loosened from femur.

• Brand Name: MRH KNEE FEM M RGT
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8623680
• MDR Text Key: 145500366
• Report Number: 0002249697-2019-01988
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327045161
• UDI-Public: 07613327045161
• Combination Product (y/n): N
• PMA/PMN Number: K002552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 64811121
• Device Lot Number: BJ69A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75