MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH LEFT HEMIPELVIS REPL SIZE E TRIDENT ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number C-M110-9-700

Device Problems Fitting Problem (2183); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that while trying to implant a custom implant in the patient's acetabulum, the implant would not fit into the patient.There was a node on the back of the implant where a screw pathway was which caused the implant to sit proud in the patient's acetabulum.The custom implant was wasted and a stryker restoration gap shell was implanted.Procedure was completed successfully with a delay of approximately 90 minutes.

Manufacturer Narrative

An event regarding size/fit issue involving a custom trident shell was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was returned for evaluation.Damage consistent with attempted implantation and subsequent explantation is visible on the device.The product design engineer reviewed the event and stated: i expect the issues encountered by the surgeon during surgery occurred primarily due to an inability to re-create the expected bone position against which the implant was designed.From the imaging and information provided by the surgeon before the custom implant was designed, the patient presented with a fully discontinuous left hemipelvis (heavily fractured), and had a cemented-in cup-cage prosthesis.The surgeon planned to remove all cement, remove all implants, and reposition the fractured bones to approximate the patient¿s pre-fracture bone position during the custom implant surgery ¿ the implant was designed as if this was all done correctly, so the implant would fit in the ¿repaired¿ bone.The bone was repaired virtually during the design process, following direction from the surgeon, and the implant was designed against this bone, incorporating feedback from the surgeon for implant size, fit, and features.The surgeon approved both the virtual bone repair and the final design of the implant.The surgeon was also warned in the approval process that fit of the implant is not guaranteed, as the patient¿s bone during surgery may not perfectly match the surgical plan for a variety of reasons, and that additional steps may be necessary during surgery for the implant to fit, or a back-up option must be used.The problem experienced by the surgeon (a ¿node¿ preventing correct implant seating) is likely related to with a failure to remove all the bone cement, or to align the bones exactly as planned, which would prevent correct implant seating.This is not solely attributable to the surgeon, as a variety of patient factors (including soft tissue limitations, a changed bone condition between the time the design started and when surgery occurred, or disease progression) may have negatively impacted the surgeon¿s ability to adhere to the surgical plan.-clinician review: the available medical records were provided for a review to the consulting clinician which concluded, " review of these records confirm multiple revision thas were performed for a periprosthetic acetabular fracture.No records were available that would indicate the cause of the fracture.Nor were any records available to document an ill fitting custom triflange acetabular component.-device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: the product design engineer reviewed the event and stated: i expect the issues encountered by the surgeon during surgery occurred primarily due to an inability to re-create the expected bone position against which the implant was designed.From the imaging and information provided by the surgeon before the custom implant was designed, the patient presented with a fully discontinuous left hemipelvis (heavily fractured), and had a cemented-in cup-cage prosthesis.The surgeon planned to remove all cement, remove all implants, and reposition the fractured bones to approximate the patient¿s pre-fracture bone position during the custom implant surgery ¿ the implant was designed as if this was all done correctly, so the implant would fit in the ¿repaired¿ bone.The bone was repaired virtually during the design process, following direction from the surgeon, and the implant was designed against this bone, incorporating feedback from the surgeon for implant size, fit, and features.The surgeon approved both the virtual bone repair and the final design of the implant.The surgeon was also warned in the approval process that fit of the implant is not guaranteed, as the patient¿s bone during surgery may not perfectly match the surgical plan for a variety of reasons, and that additional steps may be necessary during surgery for the implant to fit, or a back-up option must be used.The problem experienced by the surgeon (a ¿node¿ preventing correct implant seating) is likely related to with a failure to remove all the bone cement, or to align the bones exactly as planned, which would prevent correct implant seating.This is not solely attributable to the surgeon, as a variety of patient factors (including soft tissue limitations, a changed bone condition between the time the design started and when surgery occurred, or disease progression) may have negatively impacted the surgeon¿s ability to adhere to the surgical plan.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that while trying to implant a custom implant in the patient's acetabulum, the implant would not fit into the patient.There was a node on the back of the implant where a screw pathway was which caused the implant to sit proud in the patient's acetabulum.The custom implant was wasted and a stryker restoration gap shell was implanted.Procedure was completed successfully with a delay of approximately 90 minutes.

• Brand Name: LEFT HEMIPELVIS REPL SIZE E TRIDENT ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10454464
• MDR Text Key: 204872551
• Report Number: 0002249697-2020-01729
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-M110-9-700
• Device Lot Number: YN8PTM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR