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

Model Number	723-00-36G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.The following devices were also listed in this report: tridentii tritanium cluster60g; cat#702-04-60g ; lot# 87462001a; 6.5mm low profile hex screw 45mm; cat# 7030-6545; lot# 5hg; delta v-40 ceramic head 36/+2,5; cat# 6570-0-536; lot#91320401; high insignia collared hip stem; cat#7000-6606; lot#92303702.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "i&d and head/liner swap performed.Pt.Presented with an oozing surgical-wound.Dr.Performed an i&d of all layers of the surgical wound down to the hip joint.He swapped out the head and liner components as well, as part of his i&d protocol." spoke to rep.Surgeon suspected infection.Rep provided primary and revision usage and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT 0 DEG X3 INSERT 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14951216
• Report Number: 0002249697-2022-00981
• Device Sequence Number: 5389790
• Product Code: LPH
• UDI-Device Identifier: 07613327341706
• UDI-Public: 07613327341706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2022

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 Model Number: 723-00-36G
• Device Catalogue Number: 723-00-36G
• Device Lot Number: YT1PT0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male