MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S RGT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	6481-1-111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/19/2021
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.
Event or Problem Description
It has been reported "patient mrh femoral implant was broken and only found during the surgery on (b)(6) 2021.The last revision done around 2015".
Additional Manufacturer Narrative
Corrected data d4, h4 additional manufacturer narrative reported event an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed via provided photo and clinician review.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photos show an explanted mrh femoral component with stem, massive bone tissue and blood on it.Fracture of the lateral condyle of the femoral component was noticed.-clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports that a 23 year old gentleman underwent implantation of a tumor type prosthesis for giant cell tumor in 2009.He did very well until 2015 when a revision was carried out.He again did well until 2021 when he was felt to be on stable and intraoperatively a fracture of the lateral condyle of the femoral component was found.A successful revision was carried out.I can confirm that this event took place since i was able to review the narrative and see intraoperative and postoperative photos and x-rays.Regarding the possible root cause of this event, i cannot determine it with certainty.Loosening and breakage of these types of processes are common complications especially when implanted in an extremely young patient who is physically very active.-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: it was reported that the patient's knee was revised due to mrh femoral implant broken.The reported device was not returned however photographs were provided for review.The photos show an explanted mrh femoral component with stem, massive bone tissue and blood on it.Fracture of the lateral condyle of the femoral component was noticed.Clinician review also confirmed the event.The exact cause of the event could not be determined.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
It has been reported "patient mrh femoral implant was broken and only found during the surgery on (b)(6) 2021.The last revision done around 2015".

• Brand Name: MRH KNEE FEM S RGT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12310006
• Report Number: 0002249697-2021-01360
• Device Sequence Number: 14370297
• Product Code: MBH
• UDI-Device Identifier: 07613327045147
• UDI-Public: 07613327045147
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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 Expiration Date: 12/31/2019
• Device Model Number: 6481-1-111
• Device Catalogue Number: 64811111
• Device Lot Number: EKFED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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: 35 YR
• Patient Sex: Male