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

Model Number	6481-1-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
The following was reported through: the shield of the femoral component is broken and had to be replaced.Explanation by sales rep: lateral condylar fracture at the femoral component of the mrh joint replacement.
Event or Problem Description
The following was reported through: the shield of the femoral component is broken and had to be replaced.Explanation by sales rep: lateral condylar fracture at the femoral component of the mrh joint replacement.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving mrh femoral component was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results- visual inspection was performed as part of the material analysis report (mar).This inspection shows the fracture surfaces associated with the mrh knee and the detached piece.On visual examination, the fracture was observed through the lateral condyle of the mrh knee.A material analysis has been performed.The report concluded: review of mrh knee fem xs lft, catalogue # 6481-1-100, lot code bj99b confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the lateral condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the components.Clinical review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection was performed as part of the material analysis report (mar).This inspection shows the fracture surfaces associated with the mrh knee and the detached piece.On visual examination, the fracture was observed through the lateral condyle of the mrh knee.A material analysis has been performed.The report concluded: review of mrh knee fem xs lft, catalogue # 6481-1-100, lot code bj99b confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the lateral condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the components.

• Brand Name: MRH KNEE FEM XS LFT
• 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: 14941923
• Report Number: 0002249697-2022-00975
• Device Sequence Number: 4583347
• Product Code: KRO
• UDI-Device Identifier: 07613327045109
• UDI-Public: 07613327045109
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2023

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 Expiration Date: 02/28/2022
• Device Model Number: 6481-1-100
• Device Catalogue Number: 64811100
• Device Lot Number: BJ99B
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 04/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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: Unknown