MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRHK BUMPER INSERT - NEUTRAL; KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	64812130
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices listed in this event: catalog: 64812110, description: mrhk femoral bushing, lot: ldj297.Catalog: 64812120, description: mrh axle, lot: ctd2289.Catalog: 64813216, description: mrhk tib ins 16mm xs/s s1/s2, lot: ldh806.Catalog: 64812110, description: mrhk femoral bushing, lot: ldj296.Catalog: 64812100, description: mrh tib rot comp xs-xl, lot: 57091.Catalog: 64812140, description: mrhk tibial sleeve, lot: lco607.Catalog: 5560-s-212, description: tri cemented stem 12mmx100mm, lot: n5t37n.Catalog: 64813111, description: mrh tibial b/plt keel sml 2, lot: ec4pr.Catalog: 64952030, description: gmrs dist fem comp std l 65mm, lot: ec3tx.Catalog: 6197-9-001, description: simplex p with tobramycin 1 pack, lot: mju089.Catalog: 6197-9-001, description: simplex p with tobramycin 1 pack, lot: mku104.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
As reported: "patient had complained of some pain.[surgeon] examined implants, and patient's femur and tibia were solid [well-fixed].He exchanged the bushings, liner, rotating hinge bumper and sleeve.The sleeve did show some darkening of implant from rotating hinge activity".Patient is very active (works standing up every day).Surgeon does not know cause of pain and will refer the patient to a larger institution if pain is not resolved.

• Brand Name: MRHK BUMPER INSERT - NEUTRAL
• Common Device Name: KNEE JOINT FEMOROTIBIAL METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8253365
• Report Number: 0002249697-2019-00208
• Device Sequence Number: 19380548
• Product Code: KRO
• UDI-Device Identifier: 07613327045260
• UDI-Public: 07613327045260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K002552
• 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
• Report Date (Section B): 01/16/2019

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: 07/30/2018
• Device Catalogue Number: 64812130
• Device Lot Number: LDJ108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/16/2019
• 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: 56 YR
• Patient Weight: 54