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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Unequal Limb Length (4534)

Event Date 09/18/2015

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly on (b)(6), 2014 the patient underwent left total hip arthroplasty.He started experiencing thigh pain, had a positive bone scan with a preop diagnosis of a loose stem.During revision surgery on (b)(6), 2015 the stem was found to be well fixed however the patient had a leg length inequality and his liner and head were exchanged.

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.The following device were also listed in this report: device name#delta v-40 ceramic head 36/0 ; cat#6570-0-136 ; lot#48898302.It cannot be determined which, if any of these device may have caused or contributed to the patient's experience.

• Brand Name: TRIDENT 0° X3 INSERT 36MM 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15733313
• MDR Text Key: 303058264
• Report Number: 0002249697-2022-01583
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039535
• UDI-Public: 07613327039535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 623-00-36F
• Device Catalogue Number: 623-00-36F
• Device Lot Number: MNM13R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2014
• 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: 61 YR
• Patient Sex: Male