MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_FEMORAL COMPONENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/25/2022

Event Type  Injury  

Event Description

A patient specific implant request form was received for the patient's right hip.Noted on the form: "failure of right hip total arthroplasty.Grossly loose acetabular component.Up and in defect.Femoral component with signs of loosening proximally.Massive bone defect.".

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.

Manufacturer Narrative

Correction: mfr report #0002249697-2022-01646 was reported in error.Additional information confirms it was a competitor¿s stem that was revised, therefore, this mdr is being cancelled.

Event Description

A patient specific implant request form was received for the patient's right hip.Noted on the form: "failure of right hip total arthroplasty.Grossly loose acetabular component.Up and in defect.Femoral component with signs of loosening proximally.Massive bone defect." proposed date of surgery is blank.

• Brand Name: UNKNOWN_FEMORAL COMPONENT
• 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: 15805909
• MDR Text Key: 303734600
• Report Number: 0002249697-2022-01646
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/27/2023
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG