MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. ACCOLADE; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Lot Number 11317102 AND 26420501

Device Problems Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 09/05/2021

Event Type  Injury  

Event Description

Patient came in to ed with hip issue and was found to have potential failed hip hardware/dislocation.Patient was transferred to another hospital and taken to or two days later.Hip explants removed (stem/liner/head).Sent to manufacturer (via representative) for evaluation per surgeon request.Stryker accolade femoral stem: lot number 11317102; stryker femoral head 32 +4: lot number 26420501; stryker liner size 32 10 degree- no lot lumber visible.

• Brand Name: ACCOLADE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.; 325 corporate dr; mahwah NJ 07430
• MDR Report Key: 12681081
• MDR Text Key: 277915223
• Report Number: 12681081
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 11317102 AND 26420501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Other
• Date Report to Manufacturer: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 29565 DA
• Patient Weight: 106