MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 28F; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Model Number	690-00-28F
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	08/20/2019
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.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.
Event or Problem Description
Bipolar portion dislocated despite appropriate implant positioning with a simple twist and fall.Bipolar portion separated from head subsequently in the tissues.Residual liner came out too easily from the trident shell.
Event or Problem Description
Bipolar portion dislocated despite appropriate implant positioning with a simple twist and fall.Bipolar portion separated from head subsequently in the tissues.Residual liner came out too easily from the trident shell.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event of dislocation was confirmed through clinician review of the provided medical records.Disassociation could not be confirmed.Method & results: -product evaluation and results: the liner was returned with the head disassembled.Damage consistent with explanation damage was observed on the liner.The returned device was evaluated by a material analysis engineer who indicated: the universal head was returned disassembled from the constrained liner.Scratching was observed on the articulating surface of the constrained liner (4099-42f); this is a common damage mode of uhmwpe.Damage consistent with the explantation process was observed on the proximal surface of the constrained liner.Burnishing consistent with impingement against the hip stem was observed on the distal rim of the constrained liner.Damage consistent with contact against a hard object was observed outer articulating surface of the universal head (uh1-42-28).Energy dispersive spectroscopy (eds) showed that the outer head (uh1-42-28) was consistent with astm f75 whish is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray confirms dislocated constrained liner.Need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-device 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 reported lot.Conclusion: the event of dislocation was confirmed based on the x-rays provided.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history as well as additional serial dated x-rays are required to complete the investigation and determine a root cause.No further investigation for this event is possible at this time as no devices and /or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 28F
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9109354
• Report Number: 0002249697-2019-03309
• Device Sequence Number: 3762140
• Product Code: KWZ
• UDI-Device Identifier: 07613327025552
• UDI-Public: 07613327025552
• Combination Product (Y/N): N
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 04/30/2023
• Device Model Number: 690-00-28F
• Device Catalogue Number: 690-00-28F
• Device Lot Number: 7V5PY8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 03/13/2020
• 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: 68 YR
• Patient Weight: 83