MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML R 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6495-2-020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Device not returned to the manufacturer.
Event or Problem Description
Postoperatively, the gmrs distal femoral component was dislodged from the stem.
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a gmrs femoral component was reported.The event was confirmed via evaluation of the returned product.Method & results -product evaluation and results: visual inspection: the device, along with its packaging, was sent back for evaluation.Additionally, scratches were observed on the device, which are most likely attributable to transportation damage during the return process.Dimensional inspection: the gmrs femoral component exhibited the correct taper angle and diameter and all components were within the specified dimensional tolerance.Functional inspection: functional inspection was not performed because the event does not relate to device function.Material analysis: functional inspection was not performed because the event does not relate to device function.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate 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 gmrs femoral component exhibited the correct taper angle and diameter and all components were within the specified dimensional tolerance.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Postoperatively, the gmrs distal femoral component was dislodged from the stem.Additional information: "as for the postoperative course, cleansing debridement was performed under local anesthesia for superficial infection of the postoperative wound.After that, the patient fell and the wound was opened again and the wound was re-sutured.Wheelchair self-propelled and discharged.At the end of (b)(6) 2023, the patient had right knee pain when taking a shower and when she underwent an examination in may, it was confirmed that the implant had fallen out.In addition, recurrence of osteosarcoma was recognized from the tissue during revision surgery.".

• Brand Name: GMRS DIST FEM COMP SML R 65MM
• Common Device Name: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17123930
• Report Number: 0002249697-2023-00666
• Device Sequence Number: 6400423
• Product Code: KRO
• UDI-Device Identifier: 07613327048759
• UDI-Public: 07613327048759
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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 Model Number: 6495-2-020
• Device Catalogue Number: 64952020
• Device Lot Number: N7X4B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian