MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM XS RHT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	6481-1-101
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	04/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
On (b)(6) 2017, scopio ts was revised to mrh.There was no issue in march.On (b)(6) 2021, patient visited hospital since her leg was jerky.Fem component was disengaged from stem.It will be revised on (b)(6) 2021.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a mrh femoral component was reported.The event was confirmed via medical review.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 the provided medical information by a clinical consultant indicated: photos of x-rays undated/unlabeled.1) ap knee: hinged implant, patella is subluxed/dislocated and alta, possible lateral plateau fracture bypassed by cemented stem.Stem tips not visible.2) lateral knee: hinged implant, patella is subluxed/dislocated and alta, femoral stem/component is in extension, stem tips not visible.Brace on knee.3) ap knee: hinged implant, patella is subluxed/dislocated and alta, possible lateral plateau fracture bypassed by cemented stem.Tibial stem tip not visible.Femoral stem is not connected to the femoral component (it appears disengaged not fractured), brace in place.4) lateral knee: hinged implant, patella is dislocated and alta, femoral stem is not connected to the femoral component (it appears disengaged not fractured), brace in place.5) ap knee: hinged implant, patella is subluxed/dislocated and alta.Tibial and femoral stem tips are not visible.Femoral stem is not connected to the femoral component (it appears disengaged not fractured).Confirmation: the disengagement of the stem from the femoral component can be confirmed by the photos.Root cause: the root cause cannot be ascertained without additional medical records and/or examination of the explant.-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:  the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
On (b)(6), 2017, scopio ts was revised to mrh.There was no issue in march.On (b)(6), 2021, patient visited hospital since her leg was jerky.Fem component was disengaged from stem.It will be revised on (b)(6), 2021.

• Brand Name: MRH KNEE FEM XS RHT
• 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 NA ; EI NA ; 61498200
• MDR Report Key: 11838433
• Report Number: 0002249697-2021-00866
• Device Sequence Number: 11693655
• Product Code: KRO
• UDI-Device Identifier: 07613327045123
• UDI-Public: 07613327045123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 6481-1-101
• Device Catalogue Number: 64811101
• 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: 04/22/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 11/07/2021
• 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 Sex: Female