MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-54F
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional 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.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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
The following was reported: patient had second hip revision procedure in two months.Her third hip revision procedure in total.On this latest occasion, her hip prosthesis had dislocated similar to the previous event.Specifically, she had a trident constrained insert in-situ and the bipolar head had dislocated from the insert that it had been pre-assembled in.The insert was still in the acetabular shell but the bipolar head was completely disengaged from it.The bipolar head still had the femoral head within it which itself was still intact on the cone body implant trunnion.Update: as per intake form, the surgeon explanted the trident constrained liner, ceramic head, trident cluster shell, screws and the cone body.
Event or Problem Description
The following was reported: patient had second hip revision procedure in two months.Her third hip revision procedure in total.On this latest occasion, her hip prosthesis had dislocated similar to the previous event.Specifically, she had a trident constrained insert in-situ and the bipolar head had dislocated from the insert that it had been pre-assembled in.The insert was still in the acetabular shell but the bipolar head was completely disengaged from it.The bipolar head still had the femoral head within it which itself was still intact on the cone body implant trunnion.Update: as per intake form, the surgeon explanted the trident constrained liner, ceramic head, trident cluster shell, screws and the cone body.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated bone growth on the outer surface of the shell.The shell was returned separated from the constrained liner.Damage consistent with explantation observed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 referenced.Conclusions: it was reported that the patient was revised due to dislocation.The reason for revision of the shell was not reported or confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.

• Brand Name: TRIDENT PSL WITH PUREFIX HA 54MM
• Common Device Name: 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16867156
• Report Number: 0002249697-2023-00479
• Device Sequence Number: 5958271
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 542-11-54F
• Device Catalogue Number: 542-11-54F
• Device Lot Number: 37073802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2011
• 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 Age: 81 YR
• Patient Sex: Female