MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 16MM MD/LG M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813316
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been 1 other events for the lot referenced but the reported event is for the same patient.The following devices were also listed in this report: mrh tib rot comp xs-xl; cat# 64812100; lot# 068928, mrhk tibial sleeve; cat# 64812140; lot# ldx727, mrh tibial b/plt keel med 2; cat# 64813112; lot# eae4m, ti dur reg fluted stem 11x80mm; cat# 64786605; lot# ma1s2, unknown femoral component; cat# unknown: lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned to the manufacturer.
Event or Problem Description
It's alleged through the filing of a legal claim that the patient underwent reconstruction of his left distal femur.Two surgical interventions in the gmrs were performed in (b)(6) 2015 as a two-stage treatment for infection.This event relates to the mrh components which were explanted on (b)(6) 2015.
Additional Manufacturer Narrative
Additional info: patient's details.Correction of lot number: the following devices were also listed in this report: ti dur reg fluted stem 11x80mm, cat#64786605; lot#t2641.An event regarding infection involving an mrh insert was reported.The event was confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: procedure-related factors: infection is primarily a procedure-related complication with sometimes additional patient-related risk factors.Patient-related factors: infection is primarily a procedure-related complication with sometimes additional patient-related risk factors.The malignancy present in this patient certainly increases infection risk in complex reconstruction surgery.Device-related factors: none, consistent with type of failure through infection.Diagnosis: an infectious complication occurred in a patient with a left femoral malignant bone tumor after wide segmental resection and complex reconstruction with a gmrs/mrh construct requiring a two-stage approach to treatment with irrigation and debridement performed at 9-months replacing the femoral gmrs with a temporary antibiotic spacer construct with staged reconstruction using new gmrs/mrh devices two months later.Outcome for infection treatment was good without signs of recurrence 2-years later.Infection is not device-related.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar events for the reported lot.Another similar event was found for the sterile lot but it is for the same patient.Conclusion: the reported event for infection was confirmed.However, a root cause could not be determined based on the review of the medical records by the clinician stating "an infectious complication occurred in a patient with a left femoral malignant bone tumor after wide segmental resection and complex reconstruction with a gmrs/mrh construct requiring a two-stage approach to treatment with irrigation and debridement performed at 9-months replacing the femoral gmrs with a temporary antibiotic spacer construct with staged reconstruction using new gmrs/mrh devices two months later.Outcome for infection treatment was good without signs of recurrence 2-years later.Infection is not device-related.".
Event or Problem Description
It's alleged through the filing of a legal claim that the patient underwent reconstruction of his left distal femur.Two surgical interventions in the gmrs were performed in september and november 2015 as a two-stage treatment for infection.This event relates to the mrh components which were explanted on (b)(6) 2015.

• Brand Name: MRHK TIB INS 16MM MD/LG M2/L2
• 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: 7908195
• Report Number: 0002249697-2018-03032
• Device Sequence Number: 1484919
• Product Code: KRO
• UDI-Device Identifier: 07613327043853
• UDI-Public: 07613327043853
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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: 04/30/2017
• Device Catalogue Number: 64813316
• Device Lot Number: LCW467
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: 19 YR
• Patient Weight: 85