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

Model Number 502-11-60G

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Laxity (4526)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.Device not returned.

Event Description

It was reported that the patient's left hip was revised due to recurrent dislocation of a competitor head from a stryker liner.The surgeon wanted to adjust the shell positioning, and revised the shell, 3 screws, liner and competitor head to another shell with mdm liner, adm/ mdm insert, and another competitor head.Rep confirmed that no further information will be released by the hospital or surgeon.

Event Description

It was reported that the patient's left hip was revised due to recurrent dislocation of a competitor head from a stryker liner.The surgeon wanted to adjust the shell positioning, and revised the shell, 3 screws, liner and competitor head to another shell with mdm liner, adm/ mdm insert, and another competitor head.Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding dislocation and implantation of competitor device involving a trident liner was reported.Conclusion: it was reported that the patient's left hip was revised due to recurrent dislocation of a competitor head from a stryker liner.The surgeon wanted to adjust the shell positioning.Based on the provided information it has been determined that this event is associated with an off-label application.As per ifu only stryker product are compatible with stryker component, using styker component with competitor consider as off label use of products.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: 10507985
• MDR Text Key: 206310207
• Report Number: 0002249697-2020-01821
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540432070
• UDI-Public: 04546540432070
• 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
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

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: 11/30/2022
• Device Model Number: 502-11-60G
• Device Catalogue Number: 502-11-60G
• Device Lot Number: 61757802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85