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

Model Number 502-11-52E

Device Problems Failure to Osseointegrate (1863); Osseointegration Problem (3003)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

It was reported that the patient's hip was revised.As reported by rep: "loose acetabular shell".The shell, head and liner were revised.Update per response: "there are no allegations from surgeon against the 2 implants questioned" (revised liner and revised femoral head).

Manufacturer Narrative

Reported event: an event regarding loosening involving trident shell was reported.The event was confirmed via medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided revision op report and consultation note confirm event, need additional information; primary operative report, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: provided revision op report and consultation note confirm event, need additional information; primary operative report, clinical and past medical history, additional serial dated x-rays and examination of explanted components.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's hip was revised.As reported by rep: "loose acetabular shell".The shell, head and liner were revised.Update per response: "there are no allegations from surgeon against the 2 implants questioned" (revised liner and revised femoral head).

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9739323
• MDR Text Key: 184897652
• Report Number: 0002249697-2020-00370
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540432032
• UDI-Public: 04546540432032
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 502-11-52E
• Device Catalogue Number: 502-11-52E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 68