MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII HEMI CLUSTER56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-11-56F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Primary procedure, left hip, patient's bone quality reported as poor, anterior approach at medium angle.It was reported that the screw passed through the shell.It is unknown if the screw went through a screw hole or the dome hole.Also, when trying to implant the dome hole plug, the surgeon could not get an optimal angle for implantation and stripped the threads of the plug.The device was removed and not replaced.Rep confirmed surgery was completed successfully with no delay and that the surgeon does not plan to perform a revision.Rep also provided the implant sheet and a post-op x-ray and reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
Primary procedure, left hip, patient's bone quality reported as poor, anterior approach at medium angle.It was reported that the screw passed through the shell.It is unknown if the screw went through a screw hole or the dome hole.Also, when trying to implant the dome hole plug, the surgeon could not get an optimal angle for implantation and stripped the threads of the plug.The device was removed and not replaced.Rep confirmed surgery was completed successfully with no delay and that the surgeon does not plan to perform a revision.Rep also provided the implant sheet and a post-op x-ray and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a trident shell and a screw was reported.The event was confirmed following medical review.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "rejected for medical review: provided x-ray confirms screw in pelvis.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." 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 operative reports, progress notes, x-rays operative reports 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.

• Brand Name: TRIDENTII HEMI CLUSTER56F
• 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: 8707624
• Report Number: 0002249697-2019-02289
• Device Sequence Number: 2268130
• Product Code: LPH
• UDI-Device Identifier: 07613327380972
• UDI-Public: 07613327380972
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 702-11-56F
• Device Lot Number: 64936701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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: Other
• Patient Age: 70 YR