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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Laxity (4526)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10507985
• Report Number: 0002249697-2020-01821
• Device Sequence Number: 19150006
• Product Code: LPH
• UDI-Device Identifier: 04546540432070
• UDI-Public: 04546540432070
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 85