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

Model Number	623-00-32D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: primary tritanium hemi cluster hole cup 50mm; 502-03-50d ; a40e92.Delta v-40 ceramic head 32/-4; 6570-0-032 ; 52486301.6.5 cancellous bone screw 35mm; 2030-6535-1; x016et.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: a separate pdf included two x-rays.One was a lateral view of the right hip with an accolade stem and a trident acetabular cup.It is of poor quality so i cannot make a definite description of the x-ray findings since i cannot adjust the modalities.There may be a slight radiolucency in zone two but i cannot be sure.The position of the cup appears satisfactory.The second x-ray is an ap view of the right hip with templating overlying the cup.Again i don¿t see any significant abnormality but the template overlays the cup.Position appears satisfactory.Conclusion: the patient underwent right total hip arthroplasty in 2015 and was revised in 2021 for ¿pain¿ according to the narrative.I cannot confirm that the revision was carried out since there are no postoperative x-rays and no operation report or office notes.Regarding the root cause for the revision, i cannot determine this since i have no supporting information such as original operation report, office notes, work up for the painful hip.The revision operation note would also be helpful to determine what pathology was present if any.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: a review of the provided medical records indicated that the patient underwent right total hip arthroplasty in 2015 and was revised in 2021 for ¿pain¿ according to the narrative.I cannot confirm that the revision was carried out since there are no postoperative x-rays and no operation report or office notes.Regarding the root cause for the revision, i cannot determine this since i have no supporting information such as original operation report, office notes, work up for the painful hip.The revision operation note would also be helpful to determine what pathology was present if any.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "right hip - cup, liner, screw, head ball revision - for pain.No other info available." spoke to rep: patient was revised to a competitor acetabular side.Confirmed that no further information would be released by the hospital or surgeon.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• 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: 11732238
• Report Number: 0002249697-2021-00747
• Device Sequence Number: 3309561
• Product Code: LPH
• UDI-Device Identifier: 07613327039467
• UDI-Public: 07613327039467
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 07/31/2020
• Device Model Number: 623-00-32D
• Device Catalogue Number: 623-00-32D
• Device Lot Number: E55WMM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/27/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR