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

Model Number	6481-1-121
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2021
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 was reported by the sales rep that the mrh femoral component right side broke so it was replaced with a new one.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mrh femoral component was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection: a visual inspection of the returned device indicates that the device fractured at the connection of the femoral component and the stem.There were a number of pieces of the connection also returned which had fractured at the time of failure.The device was otherwise unremarkable.No material or manufacturing discrepancies were noted as part of the visual inspection -clinician review: i cannot completely confirm that this event took place since there is no operation note or photos of the broken implant.The radiographs were not confirmatory.There was however, corroboration of the event by the rep.Regarding the possible root cause of this event, i cannot determine it with certainty.Loosening or breakage of a tumor type implant is well known, especially in very young and active patients.-product history review: all 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 reported lot.Conclusions: it was reported that the patient was revised due to a crack/fracture of the component.Visual inspection of the returned device indicated that no material or manufacturing discrepancies were present.A review of the provided medical records by a clinician noted "the radiographs were not confirmatory.There was however, corroboration of the event by the rep.Regarding the possible root cause of this event, i cannot determine it with certainty.Loosening or breakage of a tumor type implant is well known, especially in very young and active patients." the exact cause of the event could not be determined because insufficient information was provided.Further information such as additional pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported by the sales rep that the mrh femoral component right side broke so it was replaced with a new one.

• Brand Name: MRH KNEE FEM M RGT
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12505693
• Report Number: 0002249697-2021-01593
• Device Sequence Number: 17390018
• Product Code: KRO
• UDI-Device Identifier: 07613327045161
• UDI-Public: 07613327045161
• 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: 2016
• 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): 10/19/2022

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: 02/01/2020
• Device Model Number: 6481-1-121
• Device Catalogue Number: 64811121
• Device Lot Number: EL7PP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2015
• 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: 22 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian