MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT CONSTRAINED INSERT; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-10-28G
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Trident constrained acetabular liner dismantled while reducing hip joint and due to that, the surgeon had to use normal x3 liner.Thus he had to change the head also.Pictures show the inner bipolar head of the constrained liner dissociated from the outer bearing.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was confirmed through visual inspection of the returned devices.Method & results: -product evaluation and results: the constrained liner, metal head and uhr bipolar head were returned for evaluation.Damage consistent with implantation / explantation is visible on the liner.The uhr bipolar head is disassociated from the poly liner.Material evaluation was completed and indicated the following comments: damage observed on the insert consistent with attempted implantation/explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-product history review: indicated 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 lot referenced.Conclusion: it was reported trident constrained acetabular liner got dismantle while reducing hip joint.The constrained liner, metal head and uhr bipolar head were returned for evaluation.Damage consistent with implantation / explantation is visible on the liner.The uhr bipolar head is disassociated from the poly liner.Material evaluation was completed and indicated the following comments: damage observed on the insert consistent with attempted implantation/explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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
Trident constrained acetabular liner dismantled while reducing hip joint and due to that, the surgeon had to use normal x3 liner.Thus he had to change the head also.Pictures show the inner bipolar head of the constrained liner dissociated from the outer bearing.

• Brand Name: TRIDENT CONSTRAINED INSERT
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11532031
• Report Number: 0002249697-2021-00497
• Device Sequence Number: 11886724
• Product Code: KWZ
• UDI-Device Identifier: 07613327024326
• UDI-Public: 07613327024326
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 690-10-28G
• Device Catalogue Number: 690-10-28G
• Device Lot Number: K385LW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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: Other
• Patient Age: 42 YR
• Patient Weight: 62