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

Model Number	663-00-36G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, 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/+2,5; 6570-0-536; 74569001; tridentii tritanium cluster60g; 702-04-60g; 72235901a; 6.5mm low profile hex screw 25mm;7030-6525;4tud; 6.5mm low profile hex screw 25mm;7030-6525; 4tud size 7 accolade ii 127 deg;6721-0737;56579702.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
This pi is for the i&d with head and liner exchange on (b)(6) 2020.As reported: "patient came in for i&i and [head and poly] exchange.2 weeks later presents to clinic with swelling and increased redness.Scheduled for explant and antibiotic spacer on (b)(6) 2020.Complicating conditions: joint infection.".
Event or Problem Description
This pi is for the i&d with head and liner exchange on (b)(6) 2020.As reported: "patient came in for i&i and [head and poly] exchange.2 weeks later presents to clinic with swelling and increased redness.Scheduled for explant and antibiotic spacer on (b)(6) 2020.Complicating conditions: joint infection.".
Additional Manufacturer Narrative
Supplemental reason: event confirmed but no device related failure mode identified and confirmed.Reported event: an event regarding infection involving a trident liner was reported.The event was confirmed based on medical review.No device related failure mode were identified and confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-clinician review: a review of the provided medical records by a clinical consultant stated that : a revision surgery was performed for infection with ultimate resection arthoplasty and placement of antibiotic spacer.The infection had no apparent relation to the implant utilized.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other lot referenced.Conclusion - it was reported that patient hip was revised due to infection.The event was confirmed base on medical review.But it was deemed that none was clearly related to implant.A microbiological assessment was completed and concluded that due to the nature of the organism isolated - susceptible to various modes of sterilisation - and the sterilisation methodology employed by stryker, it's not probable that staphylococcus epidermidis could have originated from the implants.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.The internal investigation of sterilization process and records confirmed the product met sal 10-6 per corresponding iso standards.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: TRIDENT X3 ECCENTRIC 0 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: 10453821
• Report Number: 0002249697-2020-01715
• Device Sequence Number: 4093191
• Product Code: LPH
• UDI-Device Identifier: 07613327024722
• UDI-Public: 07613327024722
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 09/30/2022
• Device Model Number: 663-00-36G
• Device Catalogue Number: 663-00-36G
• Device Lot Number: MT8DWX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 107