MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	540-11-58G
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	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: trident 0° x3 insert 36 mm id; cat# 623-00-36g; lot# 6n4dpw.Delta v-40 ceramic head 36/0; cat# 6570-0-136; lot# 55816804.Size 4 accolade ii 127 deg; cat# 6721-0435; lot# 53558101.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.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the product history records indicate the devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other similar events for the sterile lot referenced.
Event or Problem Description
It was reported that surgeon performed a revision of patient's right hip due to infection.Rep reported that cup, ball, and liner were revised.
Additional Manufacturer Narrative
An event regarding infection involving a trident shell was reported.The event was confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated: "patient had a pressfit right tha performed in (b)(6) 2016 and had a normal uneventful postoperative course until one year later when a small area of redness developed around his incision.This was initially treated with an oral antibiotic however there was no change in appearance.His hip was evaluated with aspirations and laboratory studies and found to be infected.The primary harm involved is infection.There is no evidence for defect in the implants or their manufacture." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot & sterile lot referenced.Conclusions: review of medical records by a consulting clinician confirmed the event, however, the root cause could not be determined as devices were not returned for evaluation and results of bloodwork for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
It was reported that surgeon performed a revision of patient's right hip due to infection.Rep reported that cup, ball, and liner were revised.

• Brand Name: TRIDENT PSL HA SOLID BACK 58MM
• 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: 6853329
• Report Number: 0002249697-2017-02718
• Device Sequence Number: 16535730
• Product Code: LPH
• UDI-Device Identifier: 04546540237866
• UDI-Public: 04546540237866
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/07/2017

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: 02/08/2021
• Device Catalogue Number: 540-11-58G
• Device Lot Number: 54428301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 12/07/2017
• 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: 57 YR
• Patient Weight: 70