MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 13X127MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64853113
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Postoperatively, the gmrs distal femoral component was dislodged from the stem.
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.Device not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a mrs stem was reported.The event was confirmed.Method & results: -device 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 the provided medical records by a clinical consultant indicated: the undated operative report verifies the patient underwent resection of the distal femur and proximal tibia for osteosarcoma followed by implantation gmrs distal femoral and proximal tibia components.One undated x-ray shows the gmrs components in their expected position.The other undated x-ray showed that the distal femoral portion of the gmrs component had disassembled from the stem.Disassembly of a gmrs femoral component is confirmed.The root cause of the component dislogement cannot be determined from the limited documentation provided.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that patient was revised due to disassociation of femoral component and stem.A review of the provided medical records by a clinical consultant indicated: the undated operative report verifies the patient underwent resection of the distal femur and proximal tibia for osteosarcoma followed by implantation gmrs distal femoral and proximal tibia components.One undated x-ray shows the gmrs components in their expected position.The other undated x-ray showed that the distal femoral portion of the gmrs component had disassembled from the stem.Disassembly of a gmrs femoral component is confirmed.The root cause of the component dislogement cannot be determined from the limited documentation provided.Further information such as device lot identification and return are needed to complete the investigation for determining root cause.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 or Problem Description
Postoperatively, the gmrs distal femoral component was dislodged from the stem.Update: " 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: MRS FEM STEM W/O BODY 13X127MM
• 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: 17123933
• Report Number: 0002249697-2023-00667
• Device Sequence Number: 12362325
• Product Code: KRO
• UDI-Device Identifier: 07613327048377
• UDI-Public: 07613327048377
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040749
• 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): 10/10/2023

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 Catalogue Number: 64853113
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 09/14/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian