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

Catalog Number	623-10-32D
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Injury (2348); Joint Dislocation (2374)
Date of Event	11/18/2016
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.Device not returned.
Event or Problem Description
"on (b)(6) 2016"."there is an x-ray of the right hip, labeled "post-dislocation", and apparently a closed reduction with sedation was performed and uncomplicated reduction was described.".
Event or Problem Description
"on (b)(6) 2016" "there is an x-ray of the right hip, labeled "post-dislocation", and apparently a closed reduction with sedation was performed and uncomplicated reduction was described".
Additional Manufacturer Narrative
Corrected data: b2 outcomes attributed to ae an event regarding dislocation involving a trident liner was reported.The event was confirmed by a review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: not performed as product remained implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: 'on (b)(6) 2016 an emergency room visit report states, " injured right hip while in the shower severe pain with movement." there is an x-ray of the right hip, labeled "post-dislocation", and apparently a closed reduction with sedation was performed and uncomplicated reduction was described.The patient was discharged home on (b)(6) 2016.On (b)(6) 2016 an office visit note states, "slipped and right hip dislocated (b)(6) 2016, closed reduction follow-up in two months."' 'x-rays dated (b)(6) 2016 are two aps and two laterals of the right hip demonstrating a posterior dislocation and one ap on that same date showing the hip post-reduction and in nominal position.' 'there is no evidence the revision surgery or periodic mild symptoms in both hips in this morbidly obese female patient was the result of factors associated with implant material or manufacturing.' 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 investigation concluded 'x-rays dated (b)(6) 2016 are two aps and two laterals of the right hip demonstrating a posterior dislocation and one ap on that same date showing the hip post-reduction and in nominal position.' no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: 8925230
• Report Number: 0002249697-2019-02950
• Device Sequence Number: 2029045
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 03/31/2012
• Device Catalogue Number: 623-10-32D
• Device Lot Number: 3Y0MED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 104