MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-40F

Device Problems Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 08/04/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding insufficient rom involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar) which indicated: explantation damage was observed on the distal surface of the insert.Damage consistent with impingement was also observed on the distal rim of the insert.A detailed image of the articulating surface of the insert is shown with scratching being observed.This is a common damage mode of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.Material analysis: a material analysis has been performed.The report concluded: [.]scratching was observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, pathology reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

Event Description

It was reported that surgeon performed a right hip revision (implanted 10 years ago) due to the trunnion of the stem being worn down to a point.Upon opening, the hip capsule, the surgeon noticed the head came off the trunnion due to the wear of the trunnion which was worn down to a point.Surgeon replaced the stem, head, and liner (cup remained implanted) and replaced with an exeter revision stem and matching components implanted at revision.Update from sales rep: the surgeon went back with a djo expert revision stem, not an exeter revision stem.Update from material analysis: damage consistent with impingement was observed on the trident liner.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• Type of Device: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8038665
• MDR Text Key: 126155874
• Report Number: 0002249697-2018-03597
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2018

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: 09/30/2013
• Device Catalogue Number: 623-00-40F
• Device Lot Number: 2J1MNE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2018
• Initial Date FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 82