MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER46C; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-46C
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 623-00-32c; trident 0 deg x3 insert 32mm id; lot# al25k6, cat# 6570-0-132; delta v-40 ceramic head 32/0; lot# 91712502, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not returned to the manufacturer.
Event or Problem Description
This pi is for the revision on (b)(6) 2022.Patient had an index left that on (b)(6) 2022.Patient had instability and dislocated, requiring closed reduction under anesthesia on (b)(6) 2022.Patient continued with instability and underwent revision on (b)(6) 2022.All components were exchanged except the stem.
Additional Manufacturer Narrative
An event regarding instability involving a trident ii shell was reported.The event was confirmed via clinician review of the provided medical records.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: "it is confirmed the patient underwent a revision of a primary tha because of recurrent dislocation.In his operative report the surgeon states that there was some anterior instability and posterior liner wear noted but the cup was in its proper position.He does not opine as to what other causes of the instability might be.The root cause of the recurrent tha cannot be determined from the documentation provided." product history review: review of the device history records indicate 24 devices were manufactured and accepted into final stock on february 12, 2022 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 instability.A review of the provided medical records by a clinical consultant indicated: "it is confirmed the patient underwent a revision of a primary tha because of recurrent dislocation.In his operative report the surgeon states that there was some anterior instability and posterior liner wear noted but the cup was in its proper position.He does not opine as to what other causes of the instability might be.The root cause of the recurrent tha cannot be determined from the documentation provided." further information such as return of the device, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for the revision on (b)(6) 2022.Patient had an index left tha on (b)(6) 2022.Patient had instability and dislocated, requiring closed reduction under anesthesia on (b)(6) 2022.Patient continued with instability and underwent revision on (b)(6) 2022.All components were exchanged except the stem.

• Brand Name: TRIDENTII TRITANIUM CLUSTER46C
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17562836
• Report Number: 0002249697-2023-00901
• Device Sequence Number: 20553095
• Product Code: LPH
• UDI-Device Identifier: 07613327343809
• UDI-Public: 07613327343809
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 02/28/2024
• Device Catalogue Number: 702-04-46C
• Device Lot Number: 70290001A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 82 KG