MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER48D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-48D
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
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.Not returned.
Event or Problem Description
It was reported that during a mako tha, the liner would not lock into the trident ii 48mm shell.The liner was removed and a second liner (same catalog #, different lot) also would not lock into the shell.Surgeon decided to implant an mdm metal liner and adm/ mdm poly insert instead, and also 'down-sized' the stem to accommodate.The first 2 liners were from loaners.Surgery was completed with a delay of approximately 30 minutes.The stem needed to be changed because we were going to use a 4; which is a 35mm neck.He was going to use a 36mm minus head but since the 36mm liners would not lock in, he had to drop down to a 3 stem which is 5mm less neck length and use a plus head option.
Event or Problem Description
It was reported that during a mako tha, the liner would not lock into the trident ii 48mm shell.The liner was removed and a second liner (same catalog #, different lot) also would not lock into the shell.Surgeon decided to implant an mdm metal liner and adm/ mdm poly insert instead, and also 'down-sized' the stem to accommodate.The first 2 liners were from loaners.Surgery was completed with a delay of approximately 30 minutes.The stem needed to be changed because we were going to use a 4; which is a 35mm neck.He was going to use a 36mm minus head but since the 36mm liners would not lock in, he had to drop down to a 3 stem which is 5mm less neck length and use a plus head option.
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a trident ii shell was reported.The event was not confirmed.Method & results: -product evaluation and results: could not be performed as the device remains implanted.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there has been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, x-rays and 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.

• Brand Name: TRIDENTII TRITANIUM CLUSTER48D
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11168884
• Report Number: 0002249697-2021-00113
• Device Sequence Number: 19723748
• Product Code: LPH
• UDI-Device Identifier: 07613327343861
• UDI-Public: 07613327343861
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• 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): 02/17/2021

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: 09/30/2025
• Device Model Number: 702-04-48D
• Device Catalogue Number: 702-04-48D
• Device Lot Number: 79906701A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/17/2021
• 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: 66 YR