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

Model Number	623-00-40E
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "revision [right] total hip done (b)(6) 2020.Labs done for infection at time of surgery were negative.Implants can not be retrieved due to hospitals policy." revision due to dissociation of the head from the stem.Liner wear noted around it's rim.V40 head, 0° poly liner, and tmzf stem were revised to a 10° 36 mm eccentric liner and competitor femoral components.No further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "revision [right] total hip done (b)(6) 2020.Labs done for infection at time of surgery were negative.Implants can not be retrieved due to hospitals policy." revision due to dissociation of the head from the stem.Liner wear noted around it's rim.V40 head, 0° poly liner, and tmzf stem were revised to a 10° 36 mm eccentric liner and competitor femoral components.No further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Re[ported event: an event regarding wear involving a trident liner was reported as part of a disassociation event between a lfit v40 cocr head and an accolade stem.The event of disassociation was confirmed through clinician review of the provided medical records.Wear of the liner was not confirmed.Method & results: product evaluation and results- no product was returned for evaluation however, photographs were provided.The photograph show a recently explanted liner.Blood is visible on the liner.Wear is visible on the rim of the liner.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: based on the x-ray and the pi report the event can be confirmed.Root cause: the root cause of the dissociation cannot be stated without additional information.Obtaining the explants may contribute to determining the root cause or evidence/source of material failure.Operative notes or clinical documents particularly intraoperative findings may also contribute.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: based on the clinician review the event of disassociation was confirmed.Wear was not confirmed.Additional information such as obtaining the explants may contribute to determining the root cause or evidence/source of material failure.Operative notes or clinical documents particularly intraoperative findings may also contribute.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text: device not returned.

• 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: 10982472
• Report Number: 0002249697-2020-02630
• Device Sequence Number: 703076
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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 Model Number: 623-00-40E
• Device Catalogue Number: 623-00-40E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/19/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: 59 YR
• Patient Weight: 91