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

Model Number 623-10-32F

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.

Event Description

He had a cement mantle fracture proximal right hip.Had a traumatic fall (b)(6) 2019 - loose, other hip required dhs (non-stryker products involved on opposite hip).Proximal femoral osteolysis.Noticed on x-ray upon noticing pain and after their trauma.Update: 27 july 2019: surgeon was revising due to signs of osteolysis.Noticed cement mantle fracture during procedure.

• Brand Name: TRIDENT 10 X3 INSERT 32MM 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 ; IE NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10434934
• MDR Text Key: 203824824
• Report Number: 0002249697-2020-01677
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039863
• UDI-Public: 07613327039863
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2020

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: 03/31/2021
• Device Model Number: 623-10-32F
• Device Catalogue Number: 623-10-32F
• Device Lot Number: 240933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 77