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

Catalog Number	623-00-40G
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: v40 cocr lfit head 40mm/+12; cat#6260-9-440; lot#mkjae.Accolade tmzf hip stem #6; cat#6020-0637; lot#38109302.Trident psl ha cluster 58mm; cat#542-11-58g.6.5 cancellous bone screw 20mm; cat#2030-6520-1; lot#mnk9tk.6.5 cancellous bone screw 25mm; cat#2030-6525-1; lot#mne1m1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A 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.Device evaluated by manufacturer? device not available.
Event or Problem Description
Patient was admitted to er due to drainage of the hip at incision site of prior total hip replacement.Symptoms outside of drainage unknown.The on-call doctor reviewed the patient's condition and after fluid tests were run, it was deemed the patient's hip was potentially infected.The patient was then scheduled for surgery to remove the implants and place a cemented antibiotic spacer.The revision surgery then took place on (b)(6) 2019, where the implants were removed, fluid and tissue sent for testing, and following positive results of infection, a cemented antibiotic spacer was implanted.No further information is available.

• 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: 8793814
• Report Number: 0002249697-2019-02574
• Device Sequence Number: 16654862
• Product Code: LPH
• UDI-Device Identifier: 07613327025361
• UDI-Public: 07613327025361
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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 Expiration Date: 10/31/2016
• Device Catalogue Number: 623-00-40G
• Device Lot Number: MKP53H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/16/2019
• 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: 64 YR