MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	500-11-52E
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: patient reports pain after thr left (thr on 03-nov-2017).Cup revision done on (b)(6) 2019.Patient also included in the hs038 atx study for right thr.Revision noted in source documentation during routine monitoring for the atx study.Patient reported pain.Pain resolved after cup revision.
Additional Manufacturer Narrative
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.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 or Problem Description
The following was reported: patient reports pain after thr left (thr on (b)(6) 2017).Cup revision done on (b)(6) 2019.Patient also included in the hs038 atx study for right thr.Revision noted in source documentation during routine monitoring for the atx study.Patient reported pain.Pain resolved after cup revision.Update 26-september-2022 mf: per medical review: "this patient underwent a primary cementless left total hip replacement on (b)(6), 2017.The patient continued to have pain in the hip and was found to have an anteverted cup.Revision was carried out on (b)(6) 2019 where the cup and liner were replaced and the femoral head was likewise replaced.".
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: "this patient underwent a primary total hip replacement with cementless components.Postoperatively it was noted that the acetabular component was anteverted.This caused symptoms for the patient and revision was carried out about a year and a half later.It is interesting that the surgeon used the same size cup for the revision.In most cases a larger cup is needed to provide secure fixation.I can confirm that the primary and revision surgery was carried out since i was able to review the x-rays and the operation reports.Regarding the root cause of the event, malposition of the acetabular component is almost always iatrogenic when it is seen on the immediate postoperative x-ray.Implants can move from the immediate postop position after weight bearing and activities but, in this case, the anteversion was present on the immediate postoperative x-ray.Therefore, i would conclude that this was due to surgical technique.I would assign no causality to the implant system." -product history review: review of the device history records indicate the 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 shell malposition.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a primary total hip replacement with cementless components.Postoperatively it was noted that the acetabular component was anteverted.This caused symptoms for the patient and revision was carried out about a year and a half later.It is interesting that the surgeon used the same size cup for the revision.In most cases a larger cup is needed to provide secure fixation.I can confirm that the primary and revision surgery was carried out since i was able to review the x-rays and the operation reports.Regarding the root cause of the event, malposition of the acetabular component is almost always iatrogenic when it is seen on the immediate postoperative x-ray.Implants can move from the immediate postop position after weight bearing and activities but, in this case, the anteversion was present on the immediate postoperative x-ray.Therefore, i would conclude that this was due to surgical technique.I would assign no causality to the implant system." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• Common Device Name: 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 NA ; EI NA ; 61498200
• MDR Report Key: 14653206
• Report Number: 0002249697-2022-00814
• Device Sequence Number: 4841862
• Product Code: LPH
• UDI-Device Identifier: 04546540431868
• UDI-Public: 04546540431868
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 500-11-52E
• Device Catalogue Number: 500-11-52E
• Device Lot Number: 60016003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 68 KG