MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-01-58F
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was confirmed through clinical review.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided x-ray by a clinical consultant indicated: provided x-ray shows likely loose acetabular component with 2 screws.Need primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.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: a review of the provided x-ray by a clinical consultant indicated: provided x-ray shows likely loose acetabular component with 2 screws.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient had a revision hip a year ago for dislocation and developed pain from a possible loose cup.Review of x-rays by a clinician states: 'provided x-ray shows likely loose acetabular component with 2 screws.'.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 58MM
• 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: 8330004
• Report Number: 0002249697-2019-00963
• Device Sequence Number: 16181731
• Product Code: LPH
• UDI-Device Identifier: 07613153073116
• UDI-Public: 07613153073116
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 08/31/2011
• Device Catalogue Number: 502-01-58F
• Device Lot Number: 19718301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/11/2019
• 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
• Patient Age: 76 YR