MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS FEMORAL JOINT REPLMNT-LFT; IMPLANT

Catalog Number 64650020

Device Problem Metal Shedding Debris (1804)

Patient Problems Pain (1994); Toxicity (2333); Osteolysis (2377)

Event Date 05/21/2014

Event Type  Injury  

Event Description

The patient underwent left proximal tibia replacement for bone tumor in 2005.In (b)(6) 2014, pain occurred around knee joint area.The patient went to the hospital and osteolysis was confirmed by x-ray at the site of screw.On (b)(6) 2014, the surgeon tried to remove the screw, but the he did not remove it.Because, black debris was noticed around the knee joint, not the site of the screw.The surgeon checked the x-ray again, and noticed the metallosis around the knee joint.The patient will be take college entrance exam in next march.So, the revision will perform from next month if it will be performed.The surgeon needs the information if there are same events and method of revision surgery asap.

Manufacturer Narrative

Additional devices listed in this report: 6467-2-012, hmrs prox tib repl, part 142.5, lot code unknown; 6467-4-011, hmrs diap anchor pc str 11x182, lot code unknown; 64669306, hmrs-m6 knee axle plug screw, lot code unknown; 64656007, hmrs wedge - 7 x 18, lot code unknown; 64656018, hmrs bearing - 18 x 24, lot code unknown; 6466-9-230, hmrs/g i-ii.Circlips, lot code unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the devices are not available for evaluation as the devices remain implanted.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

An event regarding osteolysis and black debris involving an hmrs femoral component was reported.The event was not confirmed.The devices remained implanted.Medical records received and evaluation: not performed as insufficient medical information was provided.The clinical consultant commented that the observed two smaller osteolytic defects do not fit a picture of stress-shielding which is normally more diffuse and gradual from proximal to distal.Disease recurrence should be added on the differential diagnosis list.Femoral fixation looks good.On the tibial side there probably is an overload condition near transition of tibial body to stem extender that has not (yet) caused big trouble but might create such in the future.It would be possible that one of the screws might break or actually has already broken without obvious sign of displacement on current x-ray due to shielding by the other metallic parts of the device given the pain incident earlier in the year.A clear diagnosis is therefore not possible.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return, primary and revision operative reports, pathology reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.The clinical consultant commented that a clear diagnosis was not possible with the information provided.

Event Description

The patient underwent left proximal tibia replacement for bone tumor in 2005.In (b)(6) 2014, pain occurred around knee joint area.The patient went to the hospital and osteolysis was confirmed by x-ray at the site of screw.On (b)(6) 2014, the surgeon tried to remove the screw, but the he did not remove it.Because, black debris was noticed around the knee joint, not the site of the screw.The surgeon checked the x-ray again, and noticed the metallosis around the knee joint.The patient will be take college entrance exam in next (b)(6).So, the revision will perform from next month if it will be performed.The surgeon needs the information if there are same events and method of revision surgery asap.

• Brand Name: HMRS FEMORAL JOINT REPLMNT-LFT
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4326437
• MDR Text Key: 21928988
• Report Number: 0002249697-2014-04666
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64650020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 17 YR