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

Model Number	623-00-36D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: delta v-40 ceramic head 36/+2,5; 6570-0-536;73759505.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Procedure: the patient underwent right total hip arthroplasty (b)(6) 2020.Patient was diagnosed with a dvt received anticuagulation and developed a hematoma, underwent right total hip revision (b)(6) 2020.Head and poly exchanged.
Event or Problem Description
Procedure: the patient underwent right total hip arthroplasty (b)(6) 2020.Patient was diagnosed with a dvt received anticuagulation and developed a hematoma, underwent right total hip revision (b)(6) 2020.Head and poly exchanged.
Additional Manufacturer Narrative
Reported event: an event regarding patient factors and further revision is reported involving trident liner.The event was confirmed based on medical review, but no device specific failure modes were identified or confirmed.Method & results: product evaluation and results- product inspection - 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 information by a clinical consultant indicated: adverse event identified: hematoma and infection resulting in multiple i and d procedures and ultimately in resection arthroplasty and placement of an off-labelled antibiotic loaded device in the right hip.Hazards: none clearly related to implant.Conclusion of assessment: the hematoma and infection were confirmed.The medically compromised patient underwent one documented i and d with a head and liner exchange.The second i and d with head and liner exchange and the resection arthroplasty were confirmed solely from the pi reports.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: an event regarding patient factors and further revision is reported involving trident liner.The event was confirmed based on medical review, but no device specific failure modes were identified or confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information is needed to complete the investigation for determining its root cause.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.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• 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: 10458027
• Report Number: 0002249697-2020-01741
• Device Sequence Number: 16859402
• Product Code: LPH
• UDI-Device Identifier: 07613327025309
• UDI-Public: 07613327025309
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 10/31/2024
• Device Model Number: 623-00-36D
• Device Catalogue Number: 623-00-36D
• Device Lot Number: EH8E0P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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: 72 YR
• Patient Weight: 88