MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 26MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-26I
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: trident ti foam shell -cluster; 502-02-70i; 5872501.6.5 cancellous bone screw 30mm; 2030-6530-1; 53lmca.6.5 cancellous bone screw 25mm; 2030-6525-1; 1wpmka.6.5 cancellous bone screw 25mm; 2030-6525-1 ; 0mtmma.6.5 cancellous bone screw 25mm; 2030-6525-1 ; en2mka.6.5 cancellous bone screw 35mm; 2030-6535-1;24738405.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to infection.Infection was reported to rep as being confirmed for staph.The shell, 5 screws, poly liner, and competitor stem and head were removed and a spacer placed.Rep provided the usage sheet for the previous surgery, and reported that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT 10° X3 INSERT 26MM 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: 10070787
• Report Number: 0002249697-2020-00924
• Device Sequence Number: 2628599
• Product Code: LPH
• UDI-Device Identifier: 07613327039740
• UDI-Public: 07613327039740
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 04/30/2010
• Device Model Number: 623-10-26I
• Device Catalogue Number: 623-10-26I
• Device Lot Number: 1ZEAW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/19/2020
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81