MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-36D

Device Problems Crack (1135); Material Deformation (2976); Scratched Material (3020); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Surgeon requesting wear data on explanted poly.There was no issue with the poly, he is only curious about wear rates.Product explanted during revision hip surgery.

Event Description

Surgeon requesting wear data on explanted poly.There was no issue with the poly, he is only curious about wear rates.Product explanted during revision hip surgery.Rep reported that reason for revision was "instability, patient soft tissue laxity required a more constrained insert." only the insert was revised.

Manufacturer Narrative

Additional information: lot #, expiration date; pma/510(k)#; manufacturing date.An event regarding pain and instability involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: the product was returned damaged.Visual inspection of the product shows multiple scratches and small dents on all surfaces.There is a crack on the inside surface of the liner and some discoloration on the outer surface.Material analysis observed damage on device consistent with in-service use and explantation damage.Clinician review: not performed as no medical records and/or x-rays were provided.Product history review: all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the event could not be confirmed nor the root cause of the reported event determined due to no medical records received.Further information such as primary and revision operative reports, dated x-rays and past/clinical medical history are needed for completion of the assessment.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• 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: 7373380
• MDR Text Key: 103554380
• Report Number: 0002249697-2018-00879
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K062419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 623-00-36D
• Device Lot Number: EDVMTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR