MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-40F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: trident hemispherical cluster 56mm; cat#502-01-56f; lot#unknown; v40 cocr lfit head 40mm/-4; cat#6260-9-040; lot#unknown; size 6 accolade ii 127 deg; cat#6721-0635; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Event or Problem Description
Right tha on (b)(6) 2013.Underwent 2 stage revision on (b)(6) 2014 then (b)(6) 2014 due to infection; entire tha explanted and replaced with abx spacer.Patient factor: bmi 32.
Event or Problem Description
Right tha on (b)(6) 2013 underwent 2 stage revision on (b)(6) 2014 then (b)(6) 2014 due to infection; entire tha explanted and replaced with abx spacer.Patient factor: bmi 32.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a trident liner was reported.The event was confirmed through review of the provided medical records and x-rays by a clinical consultant.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: a review of the provided medical records and/or x-rays by a clinical consultant indicated: a deep postoperative arthroplasty infection occurred 1-year post primary implantation of an accolade-ii/trident total hip.The timing and type of infection required a two-stage approach to treatment with at first all devices removed and implantation of an antibiotic containing spacer to heal the infection with secondary reconstruction of the hip 2-months later with a restoration modular/trident system.Infection was completely resolved.Conclusion: the investigation concluded that 'a deep postoperative arthroplasty infection occurred 1-year post primary implantation of an accolade-ii/trident total hip.The timing and type of infection required a two-stage approach to treatment with at first all devices removed and implantation of an antibiotic containing spacer to heal the infection with secondary reconstruction of the hip 2-months later with a restoration modular/trident system.Infection was completely resolved.' it was noted that 'the type of streptococcus bacteria is consistent with wound infection of hospital origin.' 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 0 DEG INSERT 40MM
• 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: 8561402
• Report Number: 0002249697-2019-01749
• Device Sequence Number: 1587121
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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 Catalogue Number: 623-00-40F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: 70 YR