MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 40E; LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 723-00-40E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Erythema (1840); Fever (1858); Unspecified Infection (1930); Pain (1994); Burning Sensation (2146)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

The following devices were also listed in this report: delta un.Fem hd 40mm r40 16/18; cat # 6519-1-040 ; lot# 98139501 uni adaptor sleeve v40 ti; cat # 6519-t-204 ; lot# 97859301 high insignia collared hip stem; cat # 7000-6604 ; lot# 98017701 tridentii tritanium multi 52e; cat # 709-04-52e ; lot# 98046301a 6.5mm low profile hex screw 25mm; cat # 7030-6525 ; lot# ufka2 6.5mm low profile hex screw 15mm; cat # 7030-6515 ; lot# ugy it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a trident liner was reported.The event was not confirmed.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: "a patient underwent a tha left on (b)(6)2023.She developed an infection and was taken to the or for treatment.The implants were found to be stable and a head and liner exchange and superficial and deep i and d performed.Event confirmation: a head and liner exchanged can be confirmed.While purulent material was found at the time of surgery it was not determined if this was classed as a superficial or deep infection.The bacteriology was not defined." -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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.A review of the provided medical records by a clinician was unable to confirm the event: "while purulent material was found at the time of surgery it was not determined if this was classed as a superficial or deep infection.The bacteriology was not defined." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.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.

Event Description

As reported: "left total hip revision; i&d with head/liner exchange only.S/p-increased pain and swelling along with a fever x 4 days." per operative report: "status post left total hip arthroplasty with superficial versus deep infection.

• Brand Name: TRIDENT 0 DEG X3 INSERT 40E
• Type of Device: LPH 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16820530
• MDR Text Key: 314075838
• Report Number: 0002249697-2023-00429
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327297065
• UDI-Public: 07613327297065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2023

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 Model Number: 723-00-40E
• Device Catalogue Number: 723-00-40E
• Device Lot Number: L92ERR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2023
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American