MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-11-52E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to pain, instability, and trunnionosis.Surgeon reported via pre-revision x-ray that the cup had too much anteversion.Intra-operatively, the head was found to be 'a little loose' on the trunnion.The patient's entire hip construct was revised to a restoration modular stem construct with a new head, liner and shell.While reaming for the new shell, the patient's femoral artery was severed.A vascular surgeon was brought in to address the issue and perform a bypass.The surgery was completed successfully with a delay of approximately 3 hours.The patient was eventually pronounced stable after having gone to the icu.Rep confirmed that no stryker implants or instruments contributed to the severing of the artery, and that no further information will be released by the hospital or surgeon.
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 similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17622365
• Report Number: 0002249697-2023-00943
• Device Sequence Number: 6135869
• Product Code: LPH
• UDI-Device Identifier: 04546540432032
• UDI-Public: 04546540432032
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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 Expiration Date: 09/30/2011
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 20220701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2006
• 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 Sex: Female