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

Model Number	502-11-50D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	03/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.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
It was reported by scrub technician that hip revision was required due to patient pain after the first operation since (b)(6) 2019.The x-ray, revealed that the patient's bones are not clinging to the implant cup so surgeon decided to replace new cup and the operation case is completed successfully on (b)(6) 2020.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving trident hemispherical cluster hole shell was reported.The event was confirmed based on medical record.Method & results: device evaluation and results: not performed as product was not returned clinician review: a review of the provided medical records and x-rays rejected by a clinical consultant indicated:undated, unlabelled x-ray - ap pelvis uncemented left tha with 2 screws visible in the acetabular component, a grossly loose acetabular component which has migrated to 90 degrees vertical, the hip remains reduced.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components.The unlabelled x-ray confirms the event description, but a medical report is not possible based upon a single x-ray.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: it was reported that patient had pain due to loosening.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
It was reported by scrub technician that hip revision was required due to patient pain after the first operation since july 2019.The x-ray, revealed that the patient's bones are not clinging to the implant cup so surgeon decided to replace new cup and the operation case is completed successfully on 16 march 2020.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE 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: 9949997
• Report Number: 0002249697-2020-00730
• Device Sequence Number: 3272238
• Product Code: LPH
• UDI-Device Identifier: 04546540432025
• UDI-Public: 04546540432025
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 12/31/2023
• Device Model Number: 502-11-50D
• Device Catalogue Number: 502-11-50D
• Device Lot Number: 68004302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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