MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 502-01-62G

Device Problems Malposition of Device (2616); Osseointegration Problem (3003)

Patient Problem Pain (1994)

Event Date 11/18/2019

Event Type  Injury  

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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2014 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update: "according to the (b)(6) 2019 revision operative report, he had persistent pain and was revised 5 years ago.At surgery his acetabular component was found to be in retroversion.A new stryker acetabular component was placed along with new stryker head on his accolade stem." this pi is for rev1.

Manufacturer Narrative

An event regarding loosening involving a trident shell was reported.The event was confirmed by 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 information by a clinical consultant indicated: it was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2014 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of chromium and cobalt in his blood.Update: "according to the (b)(6) 2019 revision operative report, he had persistent pain and was revised 5 years ago.At surgery his acetabular component was found to be in retroversion.A new stryker acetabular component was placed along with new stryker head on his accolade stem." as per records received for related pi "according to the (b)(6) 2019 revision operative report, he had persistent pain and was revised 5 years ago.At surgery his acetabular component was found to be in retroversion.A new stryker acetabular component was placed along with new stryker head on his accolade stem." v40 cocr lfit head 36mm/-5mm, accolade plus tmzf hip #5.Accolade plus tmzf hip stem #5, trident alumina insert 36-g, trident psl ha cluster shell 58mm, 2x 6.5mm screw 20mm, 30mm.Anatomic area: right hip materials reviewed: (b)(6) 2014: stryker pi report (b)(6) 2019: stryker pi report (b)(6) 2004: implant sheet south shore hospital.Alumina v40 taper head, 58 g trident acetabular shell psl, 00 trident alumina insert, accolade tmzf plus stem #5, 2 screws.(b)(6) 2014 hand written: nursing sheet intraoperative.Right hip.Trident acetabular shell 62-g, 35mm screw x2, dome plug, x3 trident polyethylene 36mm-g, 36mm-5mm lfit anatomic v40 head.Specimens sent to lab.(b)(6) 2019: operative note.Indications.Patient had pain and was revised 5 yrs ago.Cup was retroverted and new stryker shell and head placed on accolade stem.Did well until several months prior when he developed groin pain.X-ray showed loose cup with protrusion.Crp mildly elevated.Sed normal.Postero-lateral approach.Found cloudy granulomatous tissue.Specimens sent.No granulomatous tissue in the joint itself.Path showed no acute inflammation, chronic foreign body reaction noted.Couldn¿t get metal head off stem.Stated that corrosion products between head and stem led to osteolysis and loosening of the shell.Osteotomy performed to get out stem.Acetabulum was loose and one screw broken.Medial wall intact.New competitor trabecular metal shell implanted 74mm.3x20mm screws placed.Modular competitor stem placed.Some instability so high wall liner placed.Confirmation: a revision surgery can be confirmed on (b)(6) 2019.A prior revision surgery can be confirmed based on implant logs.The other allegations cannot be confirmed.Root cause: the root cause of the (b)(6) 2019 revision was acetabular loosening.A root cause cannot be determined for the other events without additional medical information.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: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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

It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2014 and was revised on (b)(6) 2019.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update: "according to the (b)(6) 2019 revision operative report, he had persistent pain and was revised 5 years ago.At surgery his acetabular component was found to be in retroversion.A new stryker acetabular component was placed along with new stryker head on his accolade stem." this pi is for rev1.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 62MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13110054
• MDR Text Key: 282919744
• Report Number: 0002249697-2021-02092
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613153073130
• UDI-Public: 07613153073130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 502-01-62G
• Device Catalogue Number: 502-01-62G
• Device Lot Number: 44625401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male