MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-28C
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had an open reduction for dislocation.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar events for the lot referenced for the same patient, the device was not revised.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.
Additional Manufacturer Narrative
Reported event; an event regarding dislocation involving a trident liner 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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to two pis including the product inquiry summaries, hospital admission documentation for revision left tha surgery including a history and physical, an ap x-ray of a left tha dated (b)(6) 2022, and implant records from the primary and revision thas.The event description from the product inquiries summaries state: first pi: it was reported by the health professional that there is a revision for thr update: reason for revision due to dislocation.Second pi: patient had an open reduction for dislocation.On (b)(6) 2021 the patient was involved in an mva and suffered a comminuted fracture of the posterior wall of the acetabulum with concomitant posterior dislocation of the hip.On (b)(6) 2021 the patient underwent orif and plating of the acetabulum.This subsequently got infected and was treated with antibiotics, femoral head resection and placement of an antibiotic cement spacer.Once his infection markers (crp, esr) had normalized he underwent a complex primary pressfit tha including an augmented acetabular component.One month post-operatively the tha dislocated and the patient than underwent an open reduction of the hip.The hip then dislocated again and the patient was scheduled for revision surgery.This was completed on (b)(6) 2022.Implant records from that surgery describe a head and liner exchange to a 10 degree hooded inset.The ap x-ray from 12/5 demonstrates a posterior superior dislocation of a tha.An open reduction of a tha and subsequent revision surgery is confirmed.The root cause of the recurrent dislocations cannot be determined from this limited amount of documentation product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar events for the lot referenced.The event relates to dislocation for the same device/patient, therefore no further trending is required for this commonality.Conclusion: 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
Patient had an open reduction for dislocation.

• Brand Name: TRIDENT 10° X3 INSERT 28MM ID
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16068708
• Report Number: 0002249697-2022-01946
• Device Sequence Number: 15018289
• Product Code: LPH
• UDI-Device Identifier: 07613327039771
• UDI-Public: 07613327039771
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 04/30/2026
• Device Model Number: 623-10-28C
• Device Catalogue Number: 623-10-28C
• Device Lot Number: JN82EY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian