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

Catalog Number	64952010
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	01/10/2024
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.
Event or Problem Description
It was reported that during a revision of gmrs/mrh, trunnionosis was seen on the gmrs taper junctions.Prior to revision, preoperative joint aspiration yielded dark fluid consistent with metallosis.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a gmrs femoral component was reported.The event was not confirmed.Method & results product evaluation and results: the reported device was not returned however photographs were provided for review.Photo provided showed a recently explanted devices covered in blood and tissue.There is some residue on the inner surface of the femoral component.No conclusive decision can be made from the given photos.Clinician review: a review of medical records indicates confirmation of event: i can confirm that the patient had a distal femoral replacement with a gmrs implant because i was able to see x-rays with the implant in place and explanted portions of the implant.I do not have any other supporting documentation including office notes and operation reports and preoperative x-rays.I also do not have any documentation as to why the revision took place.Root cause analysis: assuming that the event was trunnionosis of the junction of the stem extension and the distal femoral implant, the root cause cannot be determined with certainty.Causes of trunnionosis include surgical technique especially in the way that the trunnion and the stem entry into the distal femoral component, patient factors including activity level and bmi, and implant factors.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: a review of medical records indicates confirmation of event: i can confirm that the patient had a distal femoral replacement with a gmrs implant because i was able to see x-rays with the implant in place and explanted portions of the implant.I do not have any other supporting documentation including office notes and operation reports and preoperative x-rays.I also do not have any documentation as to why the revision took place.Root cause analysis: assuming that the event was trunnionosis of the junction of the stem extension and the distal femoral implant, the root cause cannot be determined with certainty.Causes of trunnionosis include surgical technique especially in the way that the trunnion and the stem entry into the distal femoral component, patient factors including activity level and bmi, and implant factors.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
It was reported that during a revision of gmrs/mrh, trunnionosis was seen on the gmrs taper junctions.Prior to revision, preoperative joint aspiration yielded dark fluid consistent with metallosis.

• Brand Name: GMRS DIST FEM COMP SML L 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 18605226
• Report Number: 0002249697-2024-00162
• Device Sequence Number: 21120649
• Product Code: KRO
• UDI-Device Identifier: 07613327048797
• UDI-Public: 07613327048797
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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 Catalogue Number: 64952010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Unknown
• Patient Weight: 97 KG
• Patient Race: White