MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA STEM #3 LEFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6265-5103

Device Problems Degraded (1153); Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problems Cyst(s) (1800); Edema (1820); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Reaction (2414); Test Result (2695)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Sales rep reported a left primary hip revision due to possible metallosis and pain.During surgery, visual cue showed a black mark and damage to trunnion and head.Component is well fixed.Rep stated surgeon implanted a mix of stryker and competitor zimmer devices for revision.

Manufacturer Narrative

An event regarding altr and pain involving a citation stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), the review noted: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.Damage consistent with the explanation processes and evidence of biological fixation was observed on the stem.Discoloration was also observed on the trunnion of the stem.A sample of the discoloration was placed on a scanning electron microscope (sem) stub for further evaluation.A material analysis has been performed.The report concluded: discoloration was observed on the stem trunnion and head taper.Explantation damage was also observed on the stem.Eds showed the stem was consistent with astm f1813 alloy and the discoloration was consistent with the stem base alloy and biological material.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: a review by a clinical consultant noted: of further relevance is that this patient had a biolox ceramic head while the stem was made of tmzf.For corrosion and pseudotumor formation, high levels of either cobalt and/or chrome are required but none of these materials is present in one of the arthroplasty devices.Titanium is not normally a cause for pseudotumor or corrosion related adverse local tissue reactions (altr).As such, it is highly unlikely that pseudotumor formation was the principal problem of this patient until proof of contrary with histopathology of retrieved tissue.The patient suffered from left anterior hip pain and muscle weakness while the fluid collections on mri were most predominantly located along the iliopsoas tendon.Both findings could be very well consistent with iliopsoas tendinitis with the iliopsoas tendon rubbing along the anterior margin of the acetabular component.Device history review: device history records indicate 16 devices were manufactured and accepted into final stock on 04 march 2008 with no relevant reported discrepancies.Complaint history review : there have been no other similar events for the lot referenced.Conclusions: a review by a clinical consultant concluded: such an underlying problem would be a more likely cause of the reported problems but would require an x-ray for verification of component (mal)position.Also more elaborate clinical findings might help solve this case that unfortunately cannot be completely solved due to especially adequate x-ray information.The reported failure mode by altr and pseudotumor is however very unlikely given the current findings.The exact cause of the event could not be determined because insufficient information was provided.Further information such as x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information becomes available, this investigation will be reopened.

Event Description

Sales rep reported a left primary hip revision due to possible metallosis and pain.During surgery, visual cue showed a black mark and damage to trunnion and head.Component is well fixed.Rep stated surgeon implanted a mix of stryker and competitor zimmer devices for revision.

• Brand Name: CITATION TMZF HA STEM #3 LEFT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6586027
• MDR Text Key: 75794344
• Report Number: 0002249697-2017-01609
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 6265-5103
• Device Lot Number: 25485502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: 06/23/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2008
• 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: 75 YR
• Patient Weight: 55