MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CITATION TMZF HA SHORT SIZE#5L; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number 6265-5205

Device Problems Degraded (1153); Material Deformation (2976)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Joint Dislocation (2374); Reaction (2414); Fluid Discharge (2686)

Event Date 03/10/2015

Event Type  Injury  

Manufacturer Narrative

An event regarding dislocation, elevated cobalt levels and fluid collection (altr) involving a citation stem was reported.Medical review noted corrosion between the head/stem junction.Method and results: product evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: review of medical records by a consulting clinician indicated: a revision of the left total hip arthroplasty was performed for a diagnosis of recurrent dislocation of the left hip, the operative report notes, "trunnion had blackish residual material on it, which was wiped off.Also noted within the head.Some staining of the tissue was gray." the acetabular insert was removed and the acetabulum was noted to be solid.The femoral component was also solid.No micromotion was noted.There is no examination of the explanted components, no histopathology report, and no mars mri diagnostic of altr available.Some corrosion after three years in situ limited to the head/trunnion junction is not unexpected or diagnostic of pathology due to altr.Anterior dislocation in extension and external rotation is likely to be recurrent and was due to inadequate tissue tension and leg length discrepancy.There is no evidence this clinical situation was the result of factors of faulty component design, manufacturing, or materials." product history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there is 1 other event for the lot referenced, however, it is for the same patient.Conclusion: an event regarding dislocation, elevated cobalt levels and fluid collection (altr) involving a citation stem was reported.Review of medical records by a consulting clinician noted corrosion limited to the head/stem junction, however the root cause could not be determined: "some corrosion after three years in situ limited to the head/trunnion junction is not unexpected or diagnostic of pathology due to altr.Anterior dislocation in extension and external rotation is likely to be recurrent and was due to inadequate tissue tension and leg length discrepancy.There is no evidence this clinical situation was the result of factors of faulty component design, manufacturing, or materials." no further investigation for this event is possible at this time.If additional information and/or device becomes available, this investigation will be reopened.

Event Description

Surgeon reported that patient had a left total hip replacement that has dislocated twice, has pain in the hip.Mri shows fluid collection and lab work shows elevated levels of cobalt.Doctor decided to revise the hip through the posterior approach.He noted upon entering the joint space a large amount of dark fluid came out.He also noted the dark discoloration of the surrounding tissues.After dislocating the hip he carefully removed the 36 mm +10 metal head.He noted the trunnion was covered in a black substance.It was noted that the existing stem and cup were well fixed in the bone.He carefully removed the 36 liner.After cleaning out the suspect tissue around the cup, he implanted a new eccentric liner.He then cleaned the trunnion and placed a titanium v40 to c taper sleeve over it, and impacted a new 36 +7.5 c taper delta biolox head.The hip was reduce.An existing cable was removed and the surgical site was closed.

• Brand Name: CITATION TMZF HA SHORT SIZE#5L
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7532761
• MDR Text Key: 108857539
• Report Number: 0002249697-2018-01509
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053528
• 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
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 6265-5205
• Device Lot Number: 37705301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2011
• 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: 73 YR
• Patient Weight: 86