MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	500-11-52E
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
When trialing during an exeter trident mdm procedure the trident shell spun out while putting the leg through a range of motion.The surgeon then decided to implant a 50mm rimfit cup.The surgeon stated that he didn¿t think the trident that he had removed was as rough as he usually expects.The implant was loose on trialing.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: the shell was returned for evaluation.Discoloration is visible on the superior surface/ ha coating of the shell.Material evaluation was completed and indicated the following comments: damage observed on the shell ha coating consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: there is not enough information for a formal review.During a primary tha the surgeon did not gain satisfactory fixation of a pressfit trident acetabular cup.A single post op xray demonstrates a cemented exeter stem matched with a cemented rimfit acetabular polyethylene cup.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 medical records by a clinical consultant stated the following comment: there is not enough information for a formal review.During a primary tha the surgeon did not gain satisfactory fixation of a pressfit trident acetabular cup.A single post op xray demonstrates a cemented exeter stem matched with a cemented rimfit acetabular polyethylene cup.The device was returned: and material analysis evaluation indicated: damage observed on the shell ha coating consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event cannot be determined as insufficient information was provided.Further information such as operative reports, clinical reports, histopathology reports, office notes and serial x-rays are needed to fully investigate the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
When trailing during an exeter trident mdm procedure the trident shell spun out while putting the leg through a range of motion.The surgeon then decided to implant a 50mm rimfit cup.The surgeon stated that he didn't think the trident that he had removed was as rough as he usually expects.The implant was loose on trailing.

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• 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: 10362251
• Report Number: 0002249697-2020-01589
• Device Sequence Number: 16798618
• Product Code: LPH
• UDI-Device Identifier: 04546540431868
• UDI-Public: 04546540431868
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 11/03/2020

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: 11/30/2024
• Device Model Number: 500-11-52E
• Device Catalogue Number: 500-11-52E
• Device Lot Number: 75233301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: 81 YR
• Patient Weight: 61