MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-36G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	11/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: citation tmzf ha stem #4 right; cat# 6265-5114; lot# 24613101.Trident psl ha solid back 60mm; cat# 540-11-60g; lot# 39nmad.V40 cocr lfit head 36mm/+5; cat# 6260-9-236; lot# a5745p.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that surgeon performed a stage 1 revision on patient's right hip due to infection (infection clinically confirmed, microorganism not reported to rep).A stem and shell which were implanted in 2008, and a head and insert which were implanted in 2016 were all explanted.
Event or Problem Description
It was reported that surgeon performed a stage 1 revision on patient's right hip due to infection (infection clinically confirmed, microorganism not reported to rep).A stem and shell which were implanted in 2008, and a head and insert which were implanted in 2016 were all explanted.
Additional Manufacturer Narrative
An event regarding infection involving a trident liner, trident shell, metal head and citation stem was reported.The event was confirmed.Method & results: product evaluation and results: not performed as no items were returned.Medical records received and evaluation:review of the medical records concluded procedure-related factors: none evident.Patient-related factors hematogenous infection originating elsewhere in the body with metastatic infection to the hip arthroplasty.Device-related factors: none, as also supported by type of bacteria as typical hospital pathogen.Diagnosis: a hematogenous metastatic infection of a right hip citation tmzf and trident arthroplasty from an infectious origin elsewhere in the body occurred 8-years after implantation.Initial treatment with irrigation and debridement 1-year before in 2016 was not successful with recurrence of the same bacterial organism requiring a stage-1 procedure with all components removed and implantation of antibiotic spacer for infection treatment in 2017.Reimplantation with final implants to be planned once the infection is under control.-product 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.Conclusions: the investigation concluded that the infection was caused by a hematogenous metastatic infection of a right hip citation tmzf and trident arthroplasty from an infectious origin elsewhere in the body occurred 8-years after implantation.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 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: 7110536
• Report Number: 0002249697-2017-03571
• Device Sequence Number: 94303
• Product Code: LPH
• UDI-Device Identifier: 07613327039931
• UDI-Public: 07613327039931
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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: 03/17/2021
• Device Catalogue Number: 623-10-36G
• Device Lot Number: 5V6L0R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/09/2018
• 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: 73 YR
• Patient Weight: 108