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

Model Number	623-00-36F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There has been 1 similar event for the lot referenced.The following devices were also listed in this report: tritanium revision acetabular; cat#509-02-58f ; lot# 2e5ktr.Delta v-40 ceramic head 36/+5; cat#6570-0-236 ; lot#58066604.Mod con dist stem 15 x 195mm; cat#6276-7-115 ; lot#caxv340f.19mm mod rev hip bdy/blt +10mm; cat#6276-1-119 ; lot#54967702.Md vit slv and 2.0mm homog cbl; cat#6704-0-510 ; lot#58842812.6.5 cancellous bone screw 30mm; cat#2030-6530-1 ; lot#ey46w8.Osteolock bone screw 30mm; cat#5260-5-030 ; lot#54936801.Osteolock bone screw 20mm; cat#5260-5-020 ; lot#51926201.Osteolock bone screw 20mm; cat#5260-5-020 ; lot#51926201.Osteolock bone screw 24mm; cat#5260-5-024 ; lot#57209801.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned to the manufacturer.
Event or Problem Description
Patient had primary total hip replacement and needed to return to the or in 11 days due to a peri-prosthetic femur fracture.During surgery the acetabulum was noted to be loose.All components exchanged.This was reported.The patient now presents with infection, and undergoes revision with all components exchanged with an off-label implant reconstruction.

• Brand Name: TRIDENT 0° 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13677954
• Report Number: 0002249697-2022-00334
• Device Sequence Number: 17521892
• Product Code: LPH
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2022

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 Expiration Date: 01/31/2022
• Device Model Number: 623-00-36F
• Device Catalogue Number: 623-00-36F
• Device Lot Number: XP548J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White