MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-36E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Patient had her first revision of primary implants performed on (b)(6) 2017 due to a subsided stem.Her second revision which was performed on (b)(6) 2017 was due to the patient experiencing three dislocation subsequent to her (b)(6) 2017 revision surgery.Explants from the (b)(6) 2017 revision identify components that were implanted in the primary case ((b)(6) 2017) and in the revision of the primary ((b)(6) 2017).
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was not confirmed.Device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there has been 1 other event for the lot referenced.This was related to periprosthetic fracture femoral fracture for the same patient and this liner was considered concomitant and not explanted.Conclusions: 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 or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient had her first revision of primary implants performed on (b)(6) 2017 due to a subsided stem.Her second revision which was performed on (b)(6) 2017 was due to the patient experiencing three dislocation subsequent to her (b)(6) 2017 revision surgery.Explants from the (b)(6) 2017 revision identify components that were implanted in the primary case ((b)(6) 2017) and in the revision of the primary ((b)(6) 2017).

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• 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: 6937343
• Report Number: 0002249697-2017-02962
• Device Sequence Number: 565958
• Product Code: LPH
• UDI-Device Identifier: 04546540432049
• UDI-Public: 04546540432049
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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: 10/03/2021
• Device Catalogue Number: 623-00-36E
• Device Lot Number: 697KJ1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 12/01/2017
• 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: 82 YR
• Patient Weight: 70