MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.Device not returned.
Event or Problem Description
Revision right total hip replacement for dislocation.Patient twisted awkwardly in car & dislocated.6weeks post thr.Primary surgery date: (b)(6) 2020.Trident liner exchanged for mdm.
Additional Manufacturer Narrative
Reported event an event regarding dislocation involving a trident liner was reported.The event was confirmed based on medical review.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 and x-rays by a clinical consultant indicated: " undated x-ray ap right hip uncemented tha dislocated.11/20/20 ed and admission notes for right hip pain.11/20/20 handwritten admission progress note describing patient with right hip pain and inability to bear weight.Implant labels - undated: 42e mdm liner, 28/48 adm/mdm x3 insert, 28/0 v-40 femoral head.Implant labels - undated: 52 trident psl ha cluster shell, trident 32/10 degree x3 insert, 32/0 v-40 lfit head, #5 accolade set, no clinical or pmh, no operative reports, no dated serial x-rays, no examination of explanted components.Based upon the x-ray provided, the event description appears to be confirmed, but insufficient data is provided to create a medical report for this case.-product history review: 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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report 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
Revision right total hip replacement for dislocation.Patient twisted awkwardly in car & dislocated.6weeks post thr.Primary surgery date:(b)(6) 2020.Trident liner exchanged for mdm.

• Brand Name: TRIDENT 10 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: 10987801
• Report Number: 0002249697-2020-02635
• Device Sequence Number: 10919933
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 12/31/2024
• Device Model Number: 623-10-32E
• Device Catalogue Number: 623-10-32E
• Device Lot Number: HM135D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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: 70 YR
• Patient Weight: 105