MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22D; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.Reported the following: the patient that received a constrained liner on (b)(6).Luxated the liner from the tritanium cup.Dr.Mentioned that the patient is difficult to instruct.The primary surgery took place in 2014 (exeter stem and tritanium solid cup).There was an acetabular revision in 2017.An mdm liner was placed.This was luxated.Revision surgery is scheduled on (b)(6).
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: the liner was returned for evaluation.Damage/scratches were observed on the surface of the liner.Damage was also observed on the rim of the liner.Material evaluation was completed and indicated the following comments: implantation/explantation damage was observed on the proximal and distal surfaces of the poly inserts.Damage consistent impingement was observed on the distal rim of the outermost insert.No materials or manufacturing defects were observed on the surfaces examined.The tritanium hemispherical solid back shell was not received for investigation.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: [.] according to the provided summary information, patient presented in (b)(6)2019 witha disassociation of the constrained bearing from the cup shell.No medical records or x-rays are available to detail these findings but another revision surgery, the third one since 2017, was scheduled for (b)(6)2019, with no information available about findings or procedure performed at this time.With only liner conversion from mdm to constrained in (b)(6)2019, all reported instability factors, in total at least four, continued to have their adverse influence on component stability with a new dislocation reported in early (b)(6)2019, within 3-months of the previous revision.Because a constrained bearing has a complex structure with multiple components, such dislocations are usually of the intraprosthetic type, in this case it appears that the insert was disassociated from the cup shell although this can not be verified due to absence of x-ray information.-product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: [.] according to the provided summary information, patient presented in (b)(6)2019 witha disassociation of the constrained bearing from the cup shell.No medical records or x-rays are available to detail these findings but another revision surgery, the third one since 2017, was scheduled for (b)(6)2019, with no information available about findings or procedure performed at this time.With only liner conversion from mdm to constrained in (b)(6)2019, all reported instability factors, in total at least four, continued to have their adverse influence on component stability with a new dislocation reported in early (b)(6)2019, within 3-months of the previous revision.Because a constrained bearing has a complex structure with multiple components, such dislocations are usually of the intraprosthetic type, in this case it appears that the insert was disassociated from the cup shell although this can not be verified due to absence of x-ray information.The event itself cannot be confirmed as insufficient information was provided.Further information such as device lot information, pre and post operative x-rays, operative reports as well s patient history and follow up notes are required to complete the investigation for determining a root cause.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 or Problem Description
Dr.Reported the following: the patient that received a constrained liner on the 23th of (b)(6) (per 2067592) luxated the liner from the tritanium cup.Dr.Mentioned that the patient is difficult to instruct.The primary surgery took place in 2014 (exeter stem and tritanium solid cup).There was an acetabular revision in 2017.An mdm liner was placed.This was luxated.Revision surgery is scheduled on june the 6th.Update (b)(6)2019 by olive flood: this event is for the 3rd revision surgery which occurred for this patient on 06 june 2019.Revision was due to disassociation between the trident liner and shell.Two previous revisions (which occurred in 2017 and 23 (b)(6)2019) both relate to dislocation.An unknown exeter stem was added to the product grid in this complaint investigation based on the medical review for limb length discrepancy and migration.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22D
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8745597
• Report Number: 0002249697-2019-02422
• Device Sequence Number: 2039996
• Product Code: KWZ
• UDI-Device Identifier: 07613327025538
• UDI-Public: 07613327025538
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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 Catalogue Number: 690-00-22D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention