MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	540-11-50E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem 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 her right hip on or about (b)(6) 2012 and was revised on (b)(6) 2019.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.Per medical review: "cup loose grossly, poly severely damage.".
Additional 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: (b)(6) 2019: operative note.Revision right hip.Preop failed right hip, loose acetabulum, osteolysis with pelvic bone loss, trunnionosis-mechanical failure of taper, altr, proximal femoral osteolysis and bone loss.Postop same plus unstable subluxating hip.Hip originally done in 2012.Increasing pain.Worse with wb.Some clunking and mechanical symptoms.To er couldn¿t walk possible acetabular component pulled out of pelvis with fx.Labs with mild increase in markers crp 1.4, esr 47.Aspiration negative.Preop screening by medicine.Intraop abductors partially torn.Femur solid, lot of wear debris into troch, cup grossly loose with abundant wear debris.Metal staining.Massive erosions in bone c/w altr and trunnion wear/corrosion.Trunnion felt to be usable.Cup loose grossly, poly severely damage and significant bone loss due to wear debris.Reconstruction performed.Augmented.Grafted, mdm placed.Confirmation: a revision surgery was performed.Polyethylene damage noted with osteolysis from wear debris and significant bone loss at acetabulum.Some corrosion noted at the taper.The other events cannot be confirmed.Root cause: the root cause of the revision was acetabular failure with bone loss as a result of wear debris induced osteolysis.The root cause of the other events cannot be determined as they were not confirmed.Additional information would be required.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: as per the medical review "the root cause of the revision was acetabular failure with bone loss as a result of wear debris induced osteolysis." 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: TRIDENT PSL HA SOLID BACK 50MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13572059
• Report Number: 0002249697-2022-00255
• Device Sequence Number: 17108839
• Product Code: LPH
• UDI-Device Identifier: 04546540237828
• UDI-Public: 04546540237828
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 02/28/2017
• Device Model Number: 540-11-50E
• Device Catalogue Number: 540-11-50E
• Device Lot Number: 39305101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female