MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 DEG X3 INSERT 32E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	723-10-32E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/26/2023
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 have been no other similar events for the lot referenced.Catalog numbers and lot codes of other devices listed in this report: 502-11-52e, trident hemispherical cluster hole shell , lot: 96005401.0580-1-441, exeter v40 stem 44mm no 1 , lot : g8248042.Unknown catalog, unknown metal head, lot : unknown.6215-5-001, small howmedica bone plug 1pk, lot: cppaae11bh.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient required a hip revision for infection, 1st stage hip revision.Removing an exeter v40 stem, trident hemispherical acetabular shell size 52 ,small artisan cement plug.Unsure is still had a trident x3 10 degree liner or ceramic v40 32mm head insitu as implant stickers sent from surgeon for patient said the patient had a ceramic v40 head but then the removed head appeared to be metal and the surgeon specified the patient already had this replaced but unable to give further details.Replaced with a competitor cup and liner.Stryker replaced with lfit v40 28mm head +4mm and exeter long stem 44 no2 205mm.

• Brand Name: TRIDENT 10 DEG X3 INSERT 32E
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16591373
• Report Number: 0002249697-2023-00291
• Device Sequence Number: 14724578
• Product Code: LPH
• UDI-Device Identifier: 07613327339109
• UDI-Public: 07613327339109
• 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 Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 723-10-32E
• Device Catalogue Number: 723-10-32E
• Device Lot Number: 2544KK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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: 69 YR
• Patient Sex: Female