MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° CROSSFIRE INSERT 26 MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 621-10-26D

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Right tha was performed on (b)(6) 2007.The patient started going to the hospital several years ago due to pain of the surgery site.The doctor postponed the revision surgery because no osteolysis was detected while he found loosening of the cup.However, the patient complained of increased pain after she fell down, so on (b)(6) 2024, the revision surgery was performed to replace the devices (the cup, the insert, and the head) except the stem.When the doctor checked the removed devices, it was found that inner diameter of the removed head was 22mm, which was different from inner diameter of the removed insert, 26mm.The doctor requests the stryker to investigate wear location and wear depth of the insert because he suspects that the wear of the insert is one of the root cause of the cup loosening.

Manufacturer Narrative

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 10° CROSSFIRE INSERT 26 MM ID
• Type of Device: 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19070373
• MDR Text Key: 339703536
• Report Number: 0002249697-2024-00569
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327037678
• UDI-Public: 07613327037678
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 621-10-26D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female