MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	690-00-22E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the constrained liner (inner bipolar component dissociated from the outer component).
Event or Problem Description
It was reported that the patient's left hip was revised due to dissociation of the constrained liner (inner bipolar component dissociated from the outer component).
Additional Manufacturer Narrative
An event regarding disassociation involving a trident liner was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: the trident liner was retuned for evaluation.Damage consistent with explanation observed on the poly liner.The uhr bipolar head had disassociated from the liner while the metal ring disassociated from the poly liner.-clinician review: no medical records were received for review with a clinical consultant.-device history review: not performed as lot number is unknown.-complaint history review: not performed as lot number is unknown.Conclusions: it was reported that the patient was revised due to disassociation of the constrain liner.Visual inspection: the trident liner was retuned for evaluation.Damage consistent with explanation observed on the poly liner.The uhr bipolar head had disassociated from the liner while the metal ring disassociated from the poly liner.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.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22E
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18054062
• Report Number: 0002249697-2023-01304
• Device Sequence Number: 6962512
• Product Code: KWZ
• UDI-Device Identifier: 07613327025545
• UDI-Public: 07613327025545
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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 Catalogue Number: 690-00-22E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female