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

Model Number	623-00-40F
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re (b)(6) which represents a patient for whom the event description states: "(b)(6) 2019.X-ray.Failed femoral component.Broken trunnion and displaced femoral head.(b)(6) 2019.Revision." on (b)(6) 2019 op report right tha revision dx."mechanical complication right hip prosthesis" ".Right ant.Tha 2011.Accolade.Implant.Complain clicking for 2 months.Getting up a few days ago.Pain and unable to weight bear.X-ray dislocation of femoral head." spinal anesthesia, post-lat approach ".Significant metallosis and trunnion wear.Removed stem and acetabular liner.Cup solid fixation.New 40/0 liner, changed stem to smith and nephew 14/140 echelon stem with 40/+8 oxinium head" uncomplicated surgery.On (b)(6) 2011 implant labels: 60mm titanium hemispherical cluster shell with 1 screw, 40/0 x3 poly insert, 4.5 accolade tmzf plus stem, 40/+8 v40 lfit head.No clinical or pmh, no patient demographics, no imaging studies, no examination of explanted components, no surgical pathology report.Based upon the information available for review, no meaningful medical report is possible for this case." 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 clinical or pmh, patient demographics, imaging studies, surgical pathology report are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
Event or Problem Description
As reported in medwatch report # (b)(4): "patient was getting up out of his chair at home when he suddenly felt a pop and crack in his right hip.He presented to the ed on (b)(6) 2019 where x-rays showed a failed femoral component with presumed broken trunnion and displaced femoral head with dislocation.On (b)(6) 2019 he underwent a right total hip revision".Update 10 april 2020: revision surgery operative notes indicate that the head disassociated from the stem and the surgeon observed significant wear of the trunnion and metallosis.It is also noted that the liner demonstrated impingement with fracturing at the 1 o'clock position.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• 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: 10039337
• Report Number: 0002249697-2020-00877
• Device Sequence Number: 19511685
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: 12/31/2015
• Device Model Number: 623-00-40F
• Device Catalogue Number: 623-00-40F
• Device Lot Number: MJT247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 05/08/2020
• 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