MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS BEARING - 18 X 24; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 64656018

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

Any additional information will be reported in a supplemental report upon completion of the investigation.

Event Description

It was exchanged a hmrs of tibial proximal.Like the membrane made of polyethylene when removing the bearing bush.

Manufacturer Narrative

Product available to stryker and returned to manufacturer on; device evaluated by mfg.An event regarding an allergic reaction involving a hmrs bushing was reported.The event was confirmed through product return.Method & results: device evaluation and results: one bushing and some foreign matter was returned for evaluation.Multi directional scratches are visible on the bushing.The scratches are consistent with in vivo use and explantation damage.The mar concluded the report concluded: eds indicated the membrane to be consistent with an unknown carbon-based substance.The ftir analysis concluded: fourier- transform infrared spectroscopy (ftir) was performed on the sample at stryker orthopedics advanced technology analytical lab using a thermo fisher scientific in10 spectrometer.An average of 32 scans per spectra were taken in attenuated total reflection (atr) mode with a spectral resolution of 4 cm-1.Atr correction was used to compare results to literature.Ftir exhibited signature peaks associated with blood.Medical records received and evaluation: the medical review concluded that: a mar was requested to further analyze the material with no other information available about either the patient or other potential relevant findings during revision surgery.The mar with eds and ftir suggests this material has some similarity in signature peaks to blood remnants but is otherwise composed of an unknown carbon-based material as outlined in the mar.[.] as such, it is still clear that this material does not originate from the device.It is not a piece or part of a device that has disintegrated by some unknown cause but does represent a reaction of the body to the implantation of a device, in this case the hmrs tibial.[.] in summary, we may conclude that the reported membrane during revision of the hmrs tibial device should be considered a generic and not necessarily pathological biological reaction to the implanted device, originating in the tissues around the device and certainly not representing a failed part of one of the implanted devices.Device history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusions: the mar and ftir report concluded that the report concluded: eds indicated the membrane to be consistent with an unknown carbon-based substance.Ftir exhibited signature peaks associated with blood.The medical review concluded that generic type reaction of body tissue to an implanted foreign body material, the hmrs device, has contributed to membrane formation around the device of organic composition where the exact contribution of individual elements cannot be determined based upon lack of more detailed information.The exact cause of the event could not be determined based on the information provided.Further information such as device details, the reason for revision surgery, x-rays, operative reports, pathology reports as well as patient history and follow up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was exchanged a hmrs of tibial proximal.Like the membrane made of polyethylene when removing the bearing bush.

• Brand Name: HMRS BEARING - 18 X 24
• 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
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6816865
• MDR Text Key: 83500984
• Report Number: 0002249697-2017-02600
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K122015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64656018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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