MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 44MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-44H
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	12/28/2008
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
Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.
Additional Manufacturer Narrative
An event regarding pain involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product remains implanted.- clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: x-ray printouts include a series dated (b)(6) 2019, which is an ap of the pelvis and lateral of the right hip demonstrating bilateral uncemented total hip arthroplasties with no screws in the acetabular component.The right hip demonstrates brooker iii heterotopic ossification.X-rays dated (b)(6) 2019 are an ap of the pelvis and lateral of the right hip, which is unchanged.Based upon the information available for review, there is no indication that any symptoms described as related to the right total hip arthroplasty are due to the prosthetic components and the recall of the implanted prosthetic femoral head.Persistent lumbar pathology and radicular pain, as well as heterotopic ossification are more likely the cause of the symptoms described.-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 patient would like to know if his implants were part of a recall.The trident liner was determined not to be involved in recall.The exact cause of the event could not be determined because insufficient information was provided.Additional information including 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
Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.
Additional Manufacturer Narrative
An event regarding shell loosening and wear/metallosis involving a trident liner was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.There were no reported allegations against the liner, and it was only explanted as the entire acetabular construct was revised due to shell loosening and wear/metallosis at the stem-head interface.A full investigation is completed on the trident shell, accolade stem, and metal head within this same pi.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
Patient called stating he had a right hip replacement done on (b)(6) 2008 (correction: (b)(6) 2008) and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.Update per the medical records received: the patient was revised on (b)(6) 2023 due to metallosis/trunnionosis at the stem-head junction and loosening of the acetabular component.The entire construct was revised to competitor implants.

• Brand Name: TRIDENT 0 DEG INSERT 44MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9597978
• Report Number: 0002249697-2020-00121
• Device Sequence Number: 2499461
• Product Code: LPH
• UDI-Device Identifier: 07613327025408
• UDI-Public: 07613327025408
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 04/30/2013
• Device Model Number: 623-00-44H
• Device Catalogue Number: 623-00-44H
• Device Lot Number: KY8MHE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/06/2020; 08/26/2024
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/06/2020; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male