MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-32E
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
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 other similar events for the lot referenced.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.
Event or Problem Description
The 32 size e would not seat in the 54 size e trident ii solid shell after multiple attempts.36 size e impacted on first attempt.
Additional Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: damage observed on the insert consistent with attempted implantation.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: review of the device history records indicate that 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 reported liner would not seat in the 54 size e trident ii solid shell after multiple attempts.The liner was impacted on first attempt.Evaluation of the returned device indicated that damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined.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
The 32 size e would not seat in the 54 size e trident ii solid shell after multiple attempts.36 size e impacted on first attempt.

• Brand Name: TRIDENT 0 X3 INSERT 32MM ID
• 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: 11113647
• Report Number: 0002249697-2021-00024
• Device Sequence Number: 4314481
• Product Code: LPH
• UDI-Device Identifier: 07613327039450
• UDI-Public: 07613327039450
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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: 02/28/2025
• Device Model Number: 623-00-32E
• Device Catalogue Number: 623-00-32E
• Device Lot Number: VH12D7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/16/2021
• 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: 68 YR