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

Model Number	623-00-40F
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2006
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.Catalog numbers and lot codes of other devices listed in this report: 6021-2530 accolade (127 deg) size 2.5 accolade (127 deg) size 2.5, lot 20160801.6260-9-240 v40 cocr lfit head 40mm/+4, lot a8kmma.508-11-56f trident hemispherical multi, lot 19379401.2030-6525-1 6.5 cancellous bone screw 25mm, lot ha3mma.2030-6525-1 6.5 cancellous bone screw 25mm, lot ha3mma.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi was raised from a clinician review.Medical review indicates the patient underwent primary hip arthroplasty on (b)(6) 2006 and was subsequently admitted to hospital on (b)(6) 2006 and diagnosed with infection (staph epidermatous).He was released on (b)(6) 2006 with picc line of intravenous antibiotics for one week.This pi was raised for the infection.
Event or Problem Description
This pi was raised from a clinician review.Medical review indicates the patient underwent primary hip arthroplasty on (b)(6) 2006 and was subsequently admitted to hospital on (b)(6) 2006 and diagnosed with infection (staph epidermatous).He was released on (b)(6) 2006 with picc line of intravenous antibiotics for one week.This pi was raised for the infection.
Additional Manufacturer Narrative
Reported event.An event regarding infection involving a liner was reported.The event was not confirmed.Method & results.Product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.Clinician review: medical records were provided but nothing related to this event was noted.Product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 14 june 2006 with no relevant reported discrepancies.Complaint history review: there has been 1 other similar event for the lot referenced.For the same device and patient.Conclusions: 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 return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become 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: 10941775
• Report Number: 0002249697-2020-02590
• Device Sequence Number: 19629804
• Product Code: LPH
• UDI-Device Identifier: 07613327025316
• UDI-Public: 07613327025316
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 06/30/2011
• Device Model Number: 623-00-40F
• Device Catalogue Number: 623-00-40F
• Device Lot Number: 1J8MKA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/22/2021
• 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: 54 YR
• Patient Weight: 93