MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML R 65MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 6495-2-020

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Post Operative Wound Infection (2446); Inadequate Osseointegration (2646)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: mrh tib rot comp xs-xl;64812100;166534.Mrhk bumper insert - neutral;64812130;ljm741.Mrhk tibial sleeve;64812140;ljr153.Mrhk tib ins 10mm xs/s s1/s2;64813210;ljm856.Mrs fem stem w/o body 13x127mm; 64853113;192496e.Gmrs small femoral bushing; 64952105;ljl233.Gmrs small femoral bushing; 64952105;ljn365.Gmrs small axle;64952115;ctd39632.Kmax stem extnr(s,m,l,xl),80mm;64768260;lcm1313.Mrh tibial b/plt keel sml 1; 64813110;h627b.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

It was reported that the patient's right knee was revised due to infection and loosening of the distal femur.A distal femur, 13x127 stem, bushings, bumper, axle, 10mm insert, rotating platform, and sleeve were revised.Rep provided the primary usage sheet and confirmed that no further information will be released.

• Brand Name: GMRS DIST FEM COMP SML R 65MM
• Type of Device: 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: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10556436
• MDR Text Key: 207720470
• Report Number: 0002249697-2020-01936
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07613327048759
• UDI-Public: 07613327048759
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6495-2-020
• Device Catalogue Number: 64952020
• Device Lot Number: HRB7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 65