MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC

Catalog Number	625-0T-36H
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding impingement (rom), crack/fracture and pain involving a trident liner was reported.Crack/fracture of the liner was confirmed on review of the provided photo.Rom and pain was not confirmed.Method & results: device evaluation and results: the device was not returned however a photo was provided.A visual inspection of this photo confirmed crack/fracture of the ceramic element of the liner.The device was otherwise unremarkable.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar relevant events for the reported lot.Conclusions: crack/fracture of the ceramic head was confirmed on review of the provided photo however the root cause could not be determined.Rom and pain was not confirmed.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available and/ or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
Dr.Stated that the cup had shifted causing an impingement on the rim of the ceramic cup which ultimately resulted in a fracture of the ceramic.Dr.Removed the ceramic liner and ceramic head.After debridement he replaced with a new ceramic liner and ceramic head.He placed a v 4toc taper sleeve resulting in a fresh trunnion.Item not explanted: 6021-0537.Lot 8509002.Update 02/october/2018: as reported in how was issue noticed: patient presented with pain.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7990761
• Report Number: 0002249697-2018-03450
• Device Sequence Number: 1572180
• Product Code: MRA
• UDI-Device Identifier: 04546540516879
• UDI-Public: 04546540516879
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: 625-0T-36H
• Device Lot Number: 12302102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/22/2018
• 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: 78 YR
• Patient Weight: 135