MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS SMALL AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6495-2-115

Device Problems Degraded (1153); Material Erosion (1214)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 07/18/2022

Event Type  Injury  

Event Description

It was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.

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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Manufacturer Narrative

Update to: device evaluated by mfg.Reported event: an event regarding wear involving a gmrs axle was reported.The event was not confirmed.Method & results: -device evaluation and results: nothing remarkable observed on the device other than damage sustained from explantation.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to including the product inquiry summary, and an ap and lateral view x-rays of a dmrs tka.The event description from the product inquiries summary states: it was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.The ap and lateral x-rays show a cemented gmrs tka in good position without evidence of mechanical complication.The limited documentation does not provide confirming evidence of a mechanical complication i.E., wear of the bushings and axle.As such the root cause for this cannot be determined.Should additional information become available i would be happy to further this assessment.-device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: an event regarding wear was reported.The device was returned for evaluation.Nothing remarkable observed on the device other than damage sustained from explantation.A review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to including the product inquiry summary, and an ap and lateral view x-rays of a dmrs tka.The event description from the product inquiries summary states: it was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.The ap and lateral x-rays show a cemented gmrs tka in good position without evidence of mechanical complication.The limited documentation does not provide confirming evidence of a mechanical complication i.E., wear of the bushings and axle.As such the root cause for this cannot be determined.Should additional information become available i would be happy to further this assessment.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the surgeon revised the axle bushings and bumper as a result of excessive wear.

• Brand Name: GMRS SMALL AXLE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15549936
• MDR Text Key: 301241949
• Report Number: 0002249697-2022-01437
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327048773
• UDI-Public: 07613327048773
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 6495-2-115
• Device Catalogue Number: 64952115
• Device Lot Number: CTD727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization