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

Model Number	723-00-36E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/23/2022
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 36/0; cat# 6570-0-136 ; lot# 96420402.Cup acetabular trident ii sizez e 52mm cluster hole; cat# unknown; lot# unknown.Screw acetabular trident ii 6.5mm 30mm hex lo-pro; cat# unknown; lot# unknown.Screw acetabular trident ii 6.5mm 25mm hex lo-pro; cat# unknown; lot# unknown.Stem femoral insignia size 6 107mm high offset collar 38.5mm neck hip; cat# unknown; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following was reported: subject admitted to the hospital for an infection and had an i&d and head and liner exchange.Rep informed that the explanted devices are no longer available.
Event or Problem Description
The following was reported: subject admitted to the hospital for an infection and had an i&d and head and liner exchange.Rep informed that the explanted devices are no longer available.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a trident liner was reported.The event was confirmed through clinician review of the provided medical records.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: this patient sustained an acute postop periprosthetic fracture treated by wound debridement and acetabular liner and femoral head exchange.I can confirm that both the primary and the revision prosthesis occurred since i was able to review the operation reports and the x-rays of the implants.I cannot confirm the root cause with certainty.Causes of acute periprosthetic infection with purulent drainage and wound disruption are multifactorial including surgical technique factors with possible contamination and less than adequate wound closure, patient factors including compliance with postoperative instructions and wound hygiene.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 or sterile lot referenced.Conclusion: a review of the provided medical information by a clinical consultant indicated: this patient sustained an acute postop periprosthetic fracture treated by wound debridement and acetabular liner and femoral head exchange.I can confirm that both the primary and the revision prosthesis occurred since i was able to review the operation reports and the x-rays of the implants.I cannot confirm the root cause with certainty.Causes of acute periprosthetic infection with purulent drainage and wound disruption are multifactorial including surgical technique factors with possible contamination and less than adequate wound closure, patient factors including compliance with postoperative instructions and wound hygiene.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16230882
• Report Number: 0002249697-2023-00065
• Device Sequence Number: 20581328
• Product Code: LPH
• UDI-Device Identifier: 07613327341959
• UDI-Public: 07613327341959
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2023

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 Model Number: 723-00-36E
• Device Catalogue Number: 723-00-36E
• Device Lot Number: 860NT0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 04/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White