MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-00-36H
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	04/21/2020
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
On (b)(6) 2014: right hip replacement, on (b)(6) 2014: dislocation right hip, on (b)(6) 2019: dislocation right hip, on (b)(6) 2020: dislocation right hip; revision surgery is planned.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: combined stem and cup malposition in very low combined anteversion contributed to a posterior dislocation of the arthroplasty at 4-weeks implantation requiring closed reduction under anaesthesia.This defines principal failure mode as procedure-related.Secondary factors to facilitate the dislocation are represented by still incomplete capsular repair at this interval (also procedure-related) in combination with a patient adverse movement (patient-related).No device-related factors are present consistent with the type of failure through instability.Does the review identify any procedural related factors that contribute to the event? stem malposition with a neutral version around 0°, cup malposition in low anteversion of 10°, incomplete capsular healing at 4 weeks post arthroplasty? does the review identify any patient related factors that contributed to the event? patient adverse movement.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been two other event for the lot referenced that relates to the same patient therefore, no additional trending is required.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other event for the lot referenced that relates to the same patient who had previous closed reduction for dislocation therefore no additional trending is required.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: combined stem and cup malposition in very low combined anteversion contributed to a posterior dislocation of the arthroplasty at 4-weeks implantation requiring closed reduction under anaesthesia.This defines principal failure mode as procedure-related.Secondary factors to facilitate the dislocation are represented by still incomplete capsular repair at this interval (also procedure-related) in combination with a patient adverse movement (patient-related).No device-related factors are present consistent with the type of failure through instability.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as no product was returned for evaluation.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: combined stem and cup malposition in very low combined anteversion contributed to a posterior dislocation of the arthroplasty at 4-weeks implantation requiring closed reduction under anaesthesia.This defines principal failure mode as procedure-related.Secondary factors to facilitate the dislocation are represented by still incomplete capsular repair at this interval (also procedure-related) in combination with a patient adverse movement (patient-related).No device-related factors are present consistent with the type of failure through instability.Does the review identify any procedural related factors that contribute to the event? stem malposition with a neutral version around 0°, cup malposition in low anteversion of 10°, incomplete capsular healing at 4 weeks post arthroplasty? does the review identify any patient related factors that contributed to the event? patient adverse movement.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been two other event for the lot referenced that relates to the same patient therefore, no additional trending is required.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been one other event for the lot referenced that relates to the same patient who had previous closed reduction for dislocation therefore no additional trending is required.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: combined stem and cup malposition in very low combined anteversion contributed to a posterior dislocation of the arthroplasty at 4-weeks implantation requiring closed reduction under anaesthesia.This defines principal failure mode as procedure-related.Secondary factors to facilitate the dislocation are represented by still incomplete capsular repair at this interval (also procedure-related) in combination with a patient adverse movement (patient-related).No device-related factors are present consistent with the type of failure through instability.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
On (b)(6) 2014: right hip replacement, on (b)(6) 2014: dislocation right hip, on (b)(6) 2019: dislocation right hip, on (b)(6) 2020: dislocation right hip, revision surgery is planned.

• Brand Name: TRIDENT 0 X3 INSERT 36MM 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: 10157130
• Report Number: 0002249697-2020-01195
• Device Sequence Number: 2911760
• Product Code: LPH
• UDI-Device Identifier: 07613327039559
• UDI-Public: 07613327039559
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 07/31/2017
• Device Model Number: 623-00-36H
• Device Catalogue Number: 623-00-36H
• Device Lot Number: 40979701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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
• Patient Age: 76 YR
• Patient Weight: 90