MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36MM ID E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	623-00-36E
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon called me after a revision of an accolade tmzf stem.The surgeon said that stem/head has almost an identical issue as another revision he did in february.He said that the stem trunnion is worn and damaged and so is the head.There is poly backside wear, where it looks like a thin film of plastic has delaminated from the back of the liner.He said the liner is worn but not failed.He said the patient has had 4-5months of pain in the hip, unknown origin, they twisted in the kitchen the week before, and suddenly couldn't weight bear anymore.There was lots of metallosis in the patient.I will add more notes to this after getting more details from the surgeon in the coming days.Posterior approach, left hip.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar 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.
Additional Manufacturer Narrative
An event regarding disassociation of the metal head from the accolade stem 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.The patient was revised due to wear of the trunnion leading to disassociation of the femoral head from the stem and metallosis.Wear and small pieces of metallic debris were observed embedded in the articulating surface of the returned trident liner.Damage is consistent with third body wear from the metallic debris in the joint generated from the stem trunnion.The liner is therefore considered concomitant to the disassociation and trunnion wear/metallosis event.A full investigation is completed on the metal head and accolade stem within the 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
Surgeon called me after a revision of an accolade tmzf stem.The surgeon said that stem/head has almost an identical issue as another revision he did in february.He said that the stem trunnion is worn and damaged and so is the head.There is poly backside wear, where it looks like a thin film of plastic has delaminated from the back of the liner.He said the liner is worn but not failed.He said the patient has had 4-5months of pain in the hip, unknown origin, they twisted in the kitchen the week before, and suddenly couldn't weight bear anymore.There was lots of metallosis in the patient.I will add more notes to this after getting more details from the surgeon in the coming days.Posterior approach, left hip.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36MM ID E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19424534
• Report Number: 0002249697-2024-00817
• Device Sequence Number: 7905686
• Product Code: JDI
• UDI-Device Identifier: 07613327039542
• UDI-Public: 07613327039542
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 10/31/2013
• Device Catalogue Number: 623-00-36E
• Device Lot Number: 28300301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2008
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 107 KG