MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK TIB INS 20MM MD/LG M2/L2; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	64813320
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	07/05/2018
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.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
It was reported that patient's right knee was revised due to aseptic loosening.Rep reported that x-rays, medical records, and further information beyond that which he provided are not available due to hospital policy.
Event or Problem Description
It was reported that patient's right knee was revised due to aseptic loosening.Rep reported that x-rays, medical records, and further information beyond that which he provided are not available due to hospital policy.
Additional Manufacturer Narrative
An event regarding loosening of the patients knee involving a mrh insert was reported.A full investigation was completed for the tibial component (reference pr 1838777) both stems (reference prs 1838778 and pr 1838779) and the mrh augment (reference pr 1838781) within this pi.Based on the information provided and the clinician review provided there is no indication or allegation that the product reported in this investigation contributed to the event and is therefore considered concomitant.It is noted that in order to remove the tibial construct, 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.

• Brand Name: MRHK TIB INS 20MM 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: 7739569
• Report Number: 0002249697-2018-02379
• Device Sequence Number: 1040820
• Product Code: KRO
• UDI-Device Identifier: 07613327043860
• UDI-Public: 07613327043860
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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: 09/30/2016
• Device Catalogue Number: 64813320
• Device Lot Number: LCO542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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: 68 YR
• Patient Weight: 86