MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 64MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-64H
Medical Device Problem Code	Mechanical Problem (1384)
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) and pain involving a trident shell was reported.The event was not confirmed.Method & results: device evaluation and results: the product was not returned; however, a photo was provided which showed noting remarkable.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: the event could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided.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.
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 (b)(6) 2018: as reported in how was issue noticed: patient presented with pain.

• Brand Name: TRIDENT PSL WITH PUREFIX HA 64MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7992457
• Report Number: 0002249697-2018-03472
• Device Sequence Number: 1572228
• Product Code: LPH
• UDI-Device Identifier: 04546540240552
• UDI-Public: 04546540240552
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 542-11-64H
• Device Lot Number: 24449601
• 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