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

Model Number	643-00-36E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection involving trident x3 elevated rim 36mm id was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant 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 and no other similar events were reported for the lot or sterile lot.Conclusion: it was reported that the patient's left leg was amputated and acetabular components removed due to infection.The event was not confirmed.Infection is a known possible adverse outcome of surgery, as noted in the instructions for use.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: trident hemispherical cluster hole shell; cat #: 502-11-52e; lot #: 60693602; v40 cocr lfit head 36mm/0; cat #: 6260-9-136; lot #: d68y01; 21mm mod rev hip bdy/blt +10mmcomponent level 9006-1-121; cat #: 6276-1-121; lot #: 57000201; d-m 2.0mm beaded cable set vit; cat #: 6704-0-520; lot #: 56712002; d-m 2.0mm beaded cable set vit; cat #: 6704-0-520; lot #: 58607809; d-m 2.0mm beaded cable set vit; cat #: 6704-0-520; lot #: 59609903; d-m 2.0mm beaded cable set vit; cat #: 6704-0-520; lot #: 59609903; d-m 2.0mm beaded cable set vit; cat #: 6704-0-520; lot #: 61682803; d-m 2.0mm beaded cable set vit; cat #: 6704-0-520; lot #: 61682803.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left leg was amputated and acetabular components removed.Patient developed an infection from an above-the-knee amputation site which was performed (b)(6) 2018.The infection spread up the leg and into the hip.Surgeon performed a disarticulation of the remainder of the patient's leg (amputation up to the pelvis) and removed the patient's acetabular components.A shell and liner implanted (b)(6) 2017 were removed, and a restoration modular stem construct, 36 +0 lfit head, and 6 sets of dall-miles cables were removed with the remainder of the patient's leg.Rep provided usage reports for the primary implantation and prior revision (pi (b)(6)), and reported that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT X3 ELEVATED RIM 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: 9996414
• Report Number: 0002249697-2020-00797
• Device Sequence Number: 4597602
• Product Code: LPH
• UDI-Device Identifier: 07613327025064
• UDI-Public: 07613327025064
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

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: 03/31/2022
• Device Model Number: 643-00-36E
• Device Catalogue Number: 643-00-36E
• Device Lot Number: 602L5Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/24/2020
• 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: Disability
• Patient Age: 78 YR
• Patient Weight: 123