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

Model Number	623-00-36E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/13/2021
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.The following devices were also listed in this report: delta v-40 ceramic head 36/-2,5; cat # 6570-0-436; lot # 81840701.Tridentii tritanium cluster54e; cat # 702-04-54e; lot # 81305201a.Size 8 accolade ii 127 deg; cat # 6721-0837; lot # 83127602.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "left hip.Revised head and liner due to possible infection.No other information available due to hospital policy." rep provided primary and revision usage and an x-ray.
Event or Problem Description
As reported: "left hip.Revised head and liner due to possible infection.No other information available due to hospital policy." rep provided primary and revision usage and an x-ray.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a trident liner was reported.The event of infection was not confirmed.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 information by a clinical consultant indicated: the patient underwent a left total hip arthroplasty in (b)(6) 2021 and subsequently developed infection requiring revision of his implant in (b)(6) 2021.I can confirm that this event took place since it was reported by the stryker rep and stryker stickers are provided.However i do not have any operation reports or notes indicating infection.Regarding the possible root cause of this event, infection six month after hip arthroplasty is most likely due to hematogenous spread.Early infections can be due to contamination at the time of surgery or as a result of wound healing problems.-product history review: review of the device history records indicate 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.There have been no other similar events for the sterile lot referenced.Conclusions: it was reported that the patient's left was revised due to possible infection.Clinician review of provided records indicated that no operation reports or notes were provided indicating infection.The event of infection was not confirmed.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as lab and surgical pathology reports, revision operative report and past medical history are needed to complete the investigation for determining 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° X3 INSERT 36MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• MDR Report Key: 12572912
• Report Number: 0002249697-2021-01669
• Device Sequence Number: 19847114
• Product Code: LPH
• UDI-Device Identifier: 07613327039542
• UDI-Public: 07613327039542
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 01/31/2026
• Device Model Number: 623-00-36E
• Device Catalogue Number: 623-00-36E
• Device Lot Number: EX4L6N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR