MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-40E
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to head dislocation and stem neck shaving.A black discoloration of the bone and soft tissue within the joint were revealed at the revision.There was no bone fragility or soft tissue loss.The cup continued to be used and the insert was replaced due to age-related wear.
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.Device not returned to the manufacturer.
Additional Manufacturer Narrative
Reported event: an event regarding wear involving a trident liner was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection of the device indicated that the outer surface of the liner which articulates with the shell is worn.Damage is consistent with delamination and material loss.The yellow discoloration observed on the liner is consistent with the absorption of synovial fluid by the device.-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 disassociation of the head from stem.Liner wear was also reported.Visual inspection of the device indicated that the outer surface of the liner which articulates with the shell is worn.Damage is consistent with delamination and material loss.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.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
Revision surgery was performed due to head dislocation and stem neck shaving.A black discoloration of the bone and soft tissue within the joint were revealed at the revision.There was no bone fragility or soft tissue loss.The cup continued to be used and the insert was replaced due to age-related wear.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15525137
• Report Number: 0002249697-2022-01421
• Device Sequence Number: 6028956
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 07/31/2015
• Device Model Number: 623-00-40E
• Device Catalogue Number: 623-00-40E
• Device Lot Number: MJL27Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2010
• 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 Sex: Unknown