MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 50MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/17/2019
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.Device not returned.
Event or Problem Description
Patient came to doctor and complained about feeling pain while walking, after x-ray found that trident v40 head dislocation.
Additional Manufacturer Narrative
Lot code was corrected.An event regarding disassociation leading to a dislocation involving a trident liner was reported.The event was confirmed through review of the provided medical records.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: review of these records confirm the head and stem of the tripolar subsequently dissociated and dislocated.In general there is a tendency towards greater instability in arthroplasties performed for fracture.In this specific instance there is evidence of probable peri-operative fracture of the greater trochanter (presence of proximal wire and screw).This fracture would compromise the hip abductor musculature and further increase the risk of instability.Following the revision surgery a majority of the greater trochanter is missing indicating complete loss of hip abductor muscular attachment.With no muscular attachment the stability of the hip was completely dependent on the capture mechanism of the cup.This mechanism subsequently failed under excessive loads leading to dissociation.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: the investigation concluded that the disassociation leading to a dislocation was caused by patient-procedure factor.There is a tendency towards greater instability in arthroplasties performed for fracture.In this specific instance there is evidence of probable peri-operative fracture of the greater trochanter (presence of proximal wire and screw).This fracture would compromise the hip abductor musculature and further increase the risk of instability.Following the revision surgery a majority of the greater trochanter is missing indicating complete loss of hip abductor muscular attachment.With no muscular attachment the stability of the hip was completely dependent on the capture mechanism of the cup.This mechanism subsequently failed under excessive loads leading to dissociation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient came to doctor and complain about feeling pain while walking, after x-ray found that trident v40 head dislocation.

• Brand Name: ALL POLY CONSTRAINED INSERT 50MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8522651
• Report Number: 0002249697-2019-01641
• Device Sequence Number: 11233691
• Product Code: KWZ
• UDI-Device Identifier: 07613327025477
• UDI-Public: 07613327025477
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 06/30/2023
• Device Catalogue Number: 69-2850
• Device Lot Number: 2D4WR9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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