MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM MULTI 56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 709-04-56F

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Inadequate Osseointegration (2646)

Event Date 08/14/2023

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: device name#6.5mm low profile hex screw 20mm; cat#7030-6520; lot#v2hh; device name#6.5mm low profile hex screw 15mm; cat#7030-6515; lot#xjw; device name#6.5mm low profile hex screw 25mm; cat#7030-6525; lot#vhgd; device name#6.5mm low profile hex screw 45mm; cat#7030-6545; lot#vkz; device name#6.5mm low profile hex screw 45mm; cat#7030-6545; lot#vkz; device name#6.5mm low profile hex screw 45mm; cat#7030-6545; lot#vr8; device name#6.5mm low profile hex screw 15mm; cat#7030-6515; lot#xc8d.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text: device not returned to the manufacturer.

Event Description

The following was reported: "the screw went past the screw hole of the shell." update: on (b)(6) 2023 old hip prothesis cup was taken out and was replaced with the new cup, good fit.Screws was placed with good attachment.The patients rehabilitation and recovery is delayed as the cup has failed and he has to undergo a new surgery.In the end of july patient underwent an x-ray due to increased pain in the hip and patient can no longer walk or move as usual but no suspect of infection or trauma.X-ray showed the cup has loosened, luxated and a few fractured screws.Revision surgery has been performed on (b)(6).

Event Description

The following was reported: "the screw went past the screw hole of the shell.".Update: on (b)(6) 2023 old hip prothesis cup was taken out and was replaced with the new cup, good fit.Screws was placed with good attachment.The patients rehabilitation and recovery is delayed as the cup has failed and he has to undergo a new surgery.In the end of july patient underwent an x-ray due to increased pain in the hip and patient can no longer walk or move as usual but no suspect of infection or trauma.X-ray showed the cup has loosened, luxated and a few fractured screws.Revision surgery has been performed on 14th august.Update as per med review: "i can confirm the dislocation, displacement of the cup and fracture of the screws since i was able to see a ct image with these findings.I can confirm the revision since i was able to review the operation report.

Manufacturer Narrative

An event regarding loosening involving a trident shell was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: "this product inquiry concerns a 77-year-old gentleman who underwent a primary total hip arthroplasty and subsequently the acetabular cup loosened, the hip dislocated and screws were fractured and a screw came through the cup into the pelvis.I can confirm the index arthroplasty since i was able to see a ct image with the total hip arthroplasty articulation in place.I can confirm the dislocation, displacement of the cup and fracture of the screws since i was able to see a ct image with these findings.I can confirm the revision since i was able to review the operation report.The root cause of this event cannot be determined with certainty.Causes of loosening of an acetabular component with dislocation of the articulation and fracture of screws are multi-factorial including surgical technique factors, and patient factors including activity level and bmi.May have pulled through the hole in the cup and other screws can fracture due to the lever arm.I would not necessarily assign any causality to the implant or the screws.".Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to loosen shell and luxated and a few fractured screws (it is unknown which screws fractured).A review of the provided medical records by a clinical consultant indicated: "this product inquiry concerns a 77-year-old gentleman who underwent a primary total hip arthroplasty and subsequently the acetabular cup loosened, the hip dislocated and screws were fractured and a screw came through the cup into the pelvis.I can confirm the index arthroplasty since i was able to see a ct image with the total hip arthroplasty articulation in place.I can confirm the dislocation, displacement of the cup and fracture of the screws since i was able to see a ct image with these findings.I can confirm the revision since i was able to review the operation report.The root cause of this event cannot be determined with certainty.Causes of loosening of an acetabular component with dislocation of the articulation and fracture of screws are multi-factorial including surgical technique factors, and patient factors including activity level and bmi.May have pulled through the hole in the cup and other screws can fracture due to the lever arm.I would not necessarily assign any causality to the implant or the screws." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

"the screw went past the screw hole of the shell." update - was the procedure completed successfully? how? - successful revision surgery (b)(6) 2023.The old hip prothesis cup was taken out and was replaced with the new cup, good fit.Screws was placed with good attachment.Patient could go home after a few days.Was there any delay caused by this event? how long? - the patients rehabilitation and recovery is delayed as the cup has failed and he has to undergo a new surgery.The delay is at least a few months.Was there need for any unanticipated medical intervention as a consequence? - in the end of (b)(6) 2023 patient underwent an x-ray due to increased pain in the hip, no suspect of infection or trauma.X-ray showed the cup has loosened, luxated and a few fractured screws.The following weeks the patient has to undergo hospital examination in another city and a ct scan before a new revision surgery can be planned.Were there any adverse consequences to the user/patient? if so, please specify: - the patient can no longer walk and move as usual, has to use crutches and wheelchair.Patient is in severe pain.(b)(6) 2023 - update as per med review: "i can confirm the dislocation, displacement of the cup and fracture of the screws since i was able to see a ct image with these findings.I can confirm the revision since i was able to review the operation report.

Manufacturer Narrative

Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed via medical review and review of the returned device.Method & results: -product evaluation and results: visual inspection of the returned shell indicated minor surface damage such as scratches and minor dents consistent with contact with explantation tooling.Some of the through holes appear damaged from contact with the heads of the screws consistent with the shell being pulled away from the acetabulum.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this product inquiry concerns a 77-year-old gentleman who underwent a primary total hip arthroplasty and subsequently the acetabular cup loosened, the hip dislocated and screws were fractured and a screw came through the cup into the pelvis.I can confirm the index arthroplasty since i was able to see a ct image with the total hip arthroplasty articulation in place.I can confirm the dislocation, displacement of the cup and fracture of the screws since i was able to see a ct image with these findings.I can confirm the revision since i was able to review the operation report.The root cause of this event cannot be determined with certainty.Causes of loosening of an acetabular component with dislocation of the articulation and fracture of screws are multi-factorial including surgical technique factors, and patient factors including activity level and bmi.May have pulled through the hole in the cup and other screws can fracture due to the lever arm.I would not necessarily assign any causality to the implant or the screws." -product history review: review of the device history records indicate 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 lot referenced.Conclusions: conclusions: it was reported that the patient was revised due to loosen shell and luxated and a few fractured screws.Visual inspection of the returned shell indicated minor surface damage such as scratches and minor dents consistent with contact with explantation tooling.Some of the through holes appear damaged from contact with the heads of the screws consistent with the shell being pulled away from the acetabulum.A review of the provided medical records by a clinical consultant indicated: "this product inquiry concerns a 77-year-old gentleman who underwent a primary total hip arthroplasty and subsequently the acetabular cup loosened, the hip dislocated and screws were fractured and a screw came through the cup into the pelvis.I can confirm the index arthroplasty since i was able to see a ct image with the total hip arthroplasty articulation in place.I can confirm the dislocation, displacement of the cup and fracture of the screws since i was able to see a ct image with these findings.I can confirm the revision since i was able to review the operation report.The root cause of this event cannot be determined with certainty.Causes of loosening of an acetabular component with dislocation of the articulation and fracture of screws are multi-factorial including surgical technique factors, and patient factors including activity level and bmi.May have pulled through the hole in the cup and other screws can fracture due to the lever arm.I would not necessarily assign any causality to the implant or the screws." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENTII TRITANIUM MULTI 56F
• 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 ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17893047
• MDR Text Key: 325249757
• Report Number: 0002249697-2023-01155
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327343977
• UDI-Public: 07613327343977
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K171768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2024

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: 709-04-56F
• Device Lot Number: 75588201A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 01/02/2024; 03/25/2024
• Supplement Dates FDA Received: 01/17/2024; 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White