MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US J-FX BIPOL SHELL&28MMLINR/49MM; MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 856749

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021, the patient underwent the bha surgery for femoral neck fracture.The surgery was proceeded according to the surgical technique and completed without any problem.On (b)(6) the surgeon noticed the patient's numerical abnormality (details unknown), and re-operation was performed on the same day.The wound was opened, the implants were removed and thoroughly cleaned.The sample was sent for culture examination, but it was not clear whether it was a prosthetic joint infection.In the re-operation, cement spacer mold containing antibiotics was prepared and placed in the hip joint.The patient will be followed up for the next several weeks to confirm that the infection has subsided, and then revision surgery (bha or tha) will be scheduled.There is no opinion from the surgeon that this event was caused by the implants.The cause of this event could not be ruled out as being the sterilization of instruments before surgery, clean field management at the time of surgery, and bacteria that the patient already had, and many possibilities are assumed.Doi: (b)(6) 2021, dor: (b)(6) 2021, unknown side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: J-FX BIPOL SHELL&28MMLINR/49MM
• Type of Device: MISCELLANEOUS HIP CUP/LINER : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12488447
• MDR Text Key: 271923789
• Report Number: 1818910-2021-20410
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 856749
• Device Lot Number: D20031375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +5 BR; CORAIL AMT COLLAR SIZE 12; J-FX BIPOL SHELL&28MMLINR/49MM; ARTICUL/EZE BALL 28 +5 BR; CORAIL AMT COLLAR SIZE 12; J-FX BIPOL SHELL&28MMLINR/49MM
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR