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

Model Number	502-11-50D
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Eight years ago, accolade tmzf, trident hemispherical ha cluster and x3 liner were implanted.The cup was found to be loose and migrating upward, so only the cup and head were revised.When the head was removed, black discoloration was observed at the interface between the delta ceramic and the accolade tmzf.The surface of the cup was so smooth that the coating was gone only on the lower part.It seems that the stress was applied to the cups and dispersed to the head and neck.There has been no experience of discoloration due to wear on delta ceramic heads (not a metal head).
Additional Manufacturer Narrative
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
Reported event: an event regarding loosening and wear involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has what appears to be bony residue adhered to the bone-interfacing section of the device.No wear is observed on the device.The ha coating appears intact.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to shell loosening.Intraoperatively, it was reported that the shell was worn and the coating had come off.Visual inspection of the returned device indicated that the device has what appears to be bony residue adhered to the bone-interfacing section of the device.No wear is observed on the device.The ha coating appears intact.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Eight years ago, accolade tmzf, trident hemispherical ha cluster and x3 liner were implanted.The cup was found to be loose and migrating upward, so only the cup and head were revised.When the head was removed, black discoloration was observed at the interface between the delta ceramic and the accolade tmzf.The surface of the cup was so smooth that the coating was gone only on the lower part.It seems that the stress was applied to the cups and dispersed to the head and neck.There has been no experience of discoloration due to wear on delta ceramic heads (not a metal head).

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13573618
• Report Number: 0002249697-2022-00261
• Device Sequence Number: 5644203
• Product Code: LZO
• UDI-Device Identifier: 04546540432025
• UDI-Public: 04546540432025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: 12/31/2018
• Device Model Number: 502-11-50D
• Device Catalogue Number: 502-11-50D
• Device Lot Number: 46182801
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female