MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIB ROT COMP XS-XL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64812100
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to fracture of an mrh femoral component involving an mrh tibial component was reported conclusion: a full investigation was completed for the fracture of the femoral component.Based on the information provided there is no indication or allegation that the product reported in this investigation contributed to the event; however, the device was found to be damaged, consistent with impingement with the femoral component.It is noted that in order to explant and replace the axle which joins the femoral and tibial constructs, the knee joint bearing components need to be disassembled and it is good surgical practice that all bearing components are revised as a precautionary measure.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.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.
Event or Problem Description
It was reported that a patient underwent a revision surgery due to fracture.The patient had an original implant in 2013, which was revised in (b)(6) 2017.This fractured again in (b)(6) 2019 and this pi is for the operation carried last week.

• Brand Name: MRH TIB ROT COMP XS-XL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9219307
• Report Number: 0002249697-2019-03578
• Device Sequence Number: 13994901
• Product Code: KRO
• UDI-Device Identifier: 07613327045208
• UDI-Public: 07613327045208
• Combination Product (Y/N): N
• PMA/510(K) Number: K002552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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 Catalogue Number: 64812100
• Device Lot Number: 103210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 72