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

Model Number	690-10-22F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/31/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient suffered a fracture in his right hip in 2012, and he underwent surgery with the placement of a prosthesis.However, around two years later, it was diagnosed that the prosthesis was infected with a fistula.A new surgical procedure was performed to remove it of the prosthesis, performing surgical debridement and placing a cement spacer with antibiotic.In a second moment, the patient underwent a new intervention to remove the spacer and place the new prosthesis, the surgery being performed on (b)(6)2014.After surgery, when performing a review consultation with the physician, he found through an examination that there had been dislocation of arthroplasty, that is, displacement of the prosthetic femoral head from its normal place with the acetabular component.A new surgical procedure was performed on (b)(6) 2015 to remove the prosthesis.The patient alleges a defect in the acetabular prosthesis, which allowed the displacement of the prosthetic femoral head from its normal place.Adverse events reported by the patient: pain, infection, shortening of the right leg, mobility restricted to wheelchair.
Additional Manufacturer Narrative
This event was reported as a result of a legal claim.Due to the ongoing litigation, no additional information is available at this time.If additional information is received it will be reported on a supplemental report.Not returned to the manufacturer.

• Brand Name: TRIDENT CONSTRAINED INSERT
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15904373
• Report Number: 0002249697-2022-01760
• Device Sequence Number: 5390514
• Product Code: KWZ
• UDI-Device Identifier: 07613327024357
• UDI-Public: 07613327024357
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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 Model Number: 690-10-22F
• Device Catalogue Number: 690-10-22F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2016
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Female