MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CUP; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Malposition of Device (2616)

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

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "patient underwent revision tha of accolade tmzf stem and lfit 40mm head and 40mm liner.The femoral head was disassociated from the stem and the trunnion appeared worn." rep reported the existence of metallosis and damage done to the greater trochanter and tissues.Review by a clinical consultant has identified trident shell malposition as a root cause.

Event Description

As reported: "patient underwent revision tha of accolade tmzf stem and lfit 40mm head and 40mm liner.The femoral head was disassociated from the stem and the trunnion appeared worn." rep reported the existence of metallosis and damage done to the greater trochanter and tissues.Review by a clinical consultant has identified trident shell malposition as a root cause.

Manufacturer Narrative

An event regarding disassociation involving an unknown trident shell was reported.The event was confirmed through review of the provided x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: procedure-related factors: cup malposition in absent anteversion and medialization.Patient-related factors: none evident.Device-related factors: none evident.Diagnosis: cup malposition in absent anteversion and medialization has contributed to overload in the bearing section of the arthroplasty causing excessive micro motion between stem taper and femoral head leading to catastrophic taper damage as final effect with dissociation of the femoral head from the taper and severe metallosis requiring revision.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that disassociation was caused by cup malposition in absent anteversion and medialization has contributed to overload in the bearing section of the arthroplasty causing excessive micro motion between stem taper and femoral head leading to catastrophic taper damage as final effect with dissociation of the femoral head from the taper and severe metallosis requiring revision.The investigation also confirmed altr minor degrees of corrosion do not necessarily have clinical impact or cause clinical symptoms.More excessive degrees of corrosion however may cause local inflammatory signs as a consequence of metal ions toxicity to soft tissue.Such conditions are usually accompanied by clinically evident metallosis, ¿black staining¿, of the soft tissues in the hip joint.Such metallosis is clearly visible on the x-ray with severe metallic debris accumulation especially near the lateral side of the proximal femur and is caused by the metal substance loss from the taper where the metallic particles are disseminated across the joint space and deposited in the tissues around.As such, there is little doubt as to the origin of the metal debris in the joint although the majority of the metal substance loss is from the stem taper side because the tmzf alloy material is softer than cochr alloy.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN TRIDENT CUP
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7299617
• MDR Text Key: 101056345
• Report Number: 0002249697-2018-00560
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

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 Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 104