MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-36F
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544); No Information (3190)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
The end user has reported: accolade stem failure at the neck of the stem.Reviewed photos of devices shows liner wear.
Event or Problem Description
The end user has reported: accolade stem failure at the neck of the stem.Reviewed photos of devices shows liner wear.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed based on inspection.Method & results: product evaluation and results: visual inspection: the device was returned in used condition and it can be observed wear and scratch marks on the surface of the liner.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: undated, unlabeled x-ray ap pelvis: uncemented right tha with displaced fracture of stem at the base of the trunnion.The modular head remains in the acetabular component.No clinical or pmh, no patient demographics, no operative reports, no dated serial x-rays, no examination of explanted components.While the event description appears to be confirmed by the single x-ray provided, insufficient information is offered to create a medical report for this case.Product 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 lot referenced.Conclusions: it was reported that liner was worn.The event was confirmed based on inspection.Visual inspection: the device was returned in used condition and it can be observed wear and scratch marks on the surface of the liner.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 10 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: 11123882
• Report Number: 0002249697-2021-00039
• Device Sequence Number: 13619814
• Product Code: LPH
• UDI-Device Identifier: 07613327039924
• UDI-Public: 07613327039924
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/05/2021

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 Expiration Date: 12/31/2012
• Device Model Number: 623-10-36F
• Device Catalogue Number: 623-10-36F
• Device Lot Number: 25232601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/05/2021
• 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