MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_GMRS FEMORAL STEM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_LIM

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Migration (4003)

Patient Problems Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 07/13/2023

Event Type  Injury  

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.

Event Description

Patient was revised due to "aseptic loosening and subsidence of a revision distal femoral replacement.".

Manufacturer Narrative

Reported event: an event regarding loosening & subsidence involving an unknown gmrs femoral stem was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "this case concerns a 70 year old female who at some point underwent a distal femoral replacement of the right knee with a rotating hinge component and gmrs implant.The implant loosened and subsided and was revised changing part of the components.About one month later the patient underwent revision for a periprosthetic fracture above the femoral implant.I can confirm that the patient had a revision procedure of the right distal femoral replacement implant and also the re-revision procedure for periprosthetic fracture since i was able to review operation reports and x-rays.The root cause of this event cannot be determined with certainty.The causes of loosening of a distal femoral replacement rotating hinge prosthesis are multifactorial including surgical technique factors including cement technique, patient factors including bone quality, activity level and bmi.The causes of periprosthetic fracture are likewise multifactorial including surgical technique especially the reaming process which could theoretically remove enough cortical bone to weaken the femur allowing for fracture upon weight-bearing, patient factors including bone quality, activity level and bmi, as well as possible trauma.No trauma was related in this history.I would not assign any causality to the implant itself.'.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to loosening & subsidence of the gmrs femoral stem.A review of medical records with a clinical consultant indicated "this case concerns a 70 year old female who at some point underwent a distal femoral replacement of the right knee with a rotating hinge component and gmrs implant.The implant loosened and subsided and was revised changing part of the components.About one month later the patient underwent revision for a periprosthetic fracture above the femoral implant.I can confirm that the patient had a revision procedure of the right distal femoral replacement implant and also the re-revision procedure for periprosthetic fracture since i was able to review operation reports and x-rays.The root cause of this event cannot be determined with certainty.The causes of loosening of a distal femoral replacement rotating hinge prosthesis are multifactorial including surgical technique factors including cement technique, patient factors including bone quality, activity level and bmi.The causes of periprosthetic fracture are likewise multifactorial including surgical technique especially the reaming process which could theoretically remove enough cortical bone to weaken the femur allowing for fracture upon weight-bearing, patient factors including bone quality, activity level and bmi, as well as possible trauma.No trauma was related in this history.I would not assign any causality to the implant itself." 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 Description

Patient was revised due to "aseptic loosening and subsidence of a revision distal femoral replacement.".

• Brand Name: UNKNOWN_GMRS FEMORAL STEM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17642059
• MDR Text Key: 322171309
• Report Number: 0002249697-2023-00963
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 10/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic