MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32F

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 05/20/2010

Event Type  Injury  

Manufacturer Narrative

An event regarding infection involving a trident liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: " on (b)(6) 2006 she underwent a primary right total hip arthroplasty for which a brief operative report describes general anesthesia and a posterolateral approach for a diagnosis of degenerative joint disease of the right hip.A crack was noted in the femur at the time of preparation of the femoral canal two dall-miles cables were placed.An x-ray report of the right total hip describes "good alignment".On (b)(6) 2010 an aspiration of the right hip under fluoroscopic control was performed for a diagnosis of complaint of swelling and fullness of the lateral and anterior greater trochanteric area.A radiology report describes no fluid aspirated.15 cc' s of sterile saline was injected with minimal amount retrieved, which was sent to the lab.No organisms and no growth was noted at one day.There is an (b)(6) 2010 admission and surgery for excision of the right thigh mass and explant of the right total hip arthroplasty.On (b)(6) 2010 a revision right total hip was performed, and the patient was subsequently discharged on (b)(6) 2010 from the original admission on (b)(6) 2010.No operative reports for either procedure are available.A discharge summary dated (b)(6) 2010 describes admission on (b)(6) 2010 for excision of mass and "during procedure, we determined that the mass had actually transformed most of her normal tissue around the hip joint into a fibrous necrotic tissue, including her gluteus maximus, medius, and minimus, and a large portion of her sciatic nerve.Dead muscle.Excised.Prosthesis.Explanted.Mass extended into pelvis.Not resected due to danger.Pre-op mri pelvic mass large.".The note further states, "post-operative hematoma.Path studies.Mass nonmalignant".The diagnosis was "ischemic fasciitis, possible pseudotumor".She was seen on (b)(6) 2010 where it was noted she had a revision of dislocated right total hip surgery on (b)(6) 2010.No operative report or records of this admission are available for review.X-ray printouts available for review include a series dated (b)(6) 2006, which is an ap of the right hip, portable, demonstrating a right uncemented total hip arthroplasty with one screw in the acetabular shell, and two dall-miles cables, one proximal and one distal to the lesser trochanter.The hip is reduced and the components are in nominal position.(b)(6) 2010 are multiple views of the previously described components with the hip dislocated.X-rays dated (b)(6) 2010 and (b)(6) 2010 demonstrate the hip reduced.No examination of the explanted components, and no mri images or reports are available.The pathology report is not diagnostic of prosthesis related reaction and pathologist in mayo clinic-suggested that infection should be ruled out.He further noted that in metal on metal prosthetic reactions, more lymphocytes are noted and eosinophils are not common.The subsequent diagnosis of chronic infection in this case could explain this entire clinical course rather than prosthesis related reaction." product history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other events for the lot referenced.The internal investigation of sterilization process and records confirmed the product met sal 10-6 per corresponding iso standards.Conclusions: the reported event was confirmed by medical review.A review of the provided medical records by a consulting clinician revealed that "on (b)(6) 2010 an aspiration of the right hip under fluoroscopic control was performed for a diagnosis of complaint of swelling and fullness of the lateral and anterior greater trochanteric area.A radiology report describes no fluid aspirated.15 cc' s of sterile saline was injected with minimal amount retrieved, which was sent to the lab.No organisms and no growth was noted at one day.No examination of the explanted components, and no mri images or reports are available.The pathology report is not diagnostic of prosthesis related reaction and pathologist in mayo clinic-suggested that infection should be ruled out.He further noted that in metal on metal prosthetic reactions, more lymphocytes are noted and eosinophils are not common.The subsequent diagnosis of chronic infection in this case could explain this entire clinical course rather than prosthesis related reaction." the exact root cause could not be determined.Additional information such as examination of the explanted components are needed to further evaluate and determine a root case.If devices or additional information become available, this investigation will be reopened.The following devices were also listed in this report: trident psl ha cluster 54mm; cat#542-11-54f; lot#ljjmda; meridian pa hip stem #5/13mm; cat#6261-0-010; lot#137469b2; alumina c-taper head 32mm/+5; cat#17-3205e; lot#16897001; ti sleeve for alumina head; cat#17-0000e; lot#lhjmea; 6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#36950305; md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#15967301; md vit slv and 2.0mm homog cbl; cat#6704-0-510; lot#14292602; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.

Event Description

As per medical records "on (b)(6) 2010 an aspiration of the right hip under fluoroscopic control was performed for a diagnosis of complaint of swelling and fullness of the lateral and anterior greater trochanteric area.".

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 8042440
• MDR Text Key: 126272413
• Report Number: 0002249697-2018-03619
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516855
• UDI-Public: 04546540516855
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 15854403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2005
• 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: 57 YR
• Patient Weight: 88