MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 DEG X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	723-10-36E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: v40 cocr lfit head 36mm/+10; cat# v40 cocr lfit head 36mm/+10; lot# 8x8k23 exeter v40(tm).Fem.Stem 37.5 ; cat# 0580-3-321; lot# g8100181 trident hemispherical cluster hole shell; cat#502-11-52e ; lot# 95086804 6.5 cancellous bone screw 35mm; cat#2030-6535-1 ; lot# 2v3vnr, 6.5 cancellous bone screw 35mm; cat# 2030-6535-1 ; lot# 3r1h0k, 6.5 cancellous bone screw 25mm; cat# 2030-6525-1 ; lot# hl3py3, 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# 73506d, and simplex tobramycin 1 pk; cat# 61971001 ; lot# tfd029.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
It was reported: patient had a 2nd revision for infection.

• Brand Name: TRIDENT 10 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15927367
• Report Number: 0002249697-2022-01779
• Device Sequence Number: 14552125
• Product Code: LPH
• UDI-Device Identifier: 07613327339611
• UDI-Public: 07613327339611
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: 723-10-36E
• Device Catalogue Number: 723-10-36E
• Device Lot Number: 636P5D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG