MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 48MM OD; HIP FEMORAL HEAD

Catalog Number 136348000

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Der states that patient had hemi hip implanted on (b)(6) 2017.Patient started experiencing pain and was brought back to or last (b)(6) 2017 and it was determined that patient had infected hemi hip.The head ball and sleeve were removed and a hip joint washout was performed.The original stem was left implanted.

Manufacturer Narrative

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

Event Description

Update sep 12, 2017.Medical records reviewed.It is indicated the patient received a hemiarthroplasty of the right hip due to displaced femoral neck fracture post fall.Approximately 7 weeks post hemiarthroplasty the patient presented to the ed with right hip pain.Infection workup revealed positive staphylococcus epidermis; the final impression concluded to be prosthetic joint infection.It is also indicated within the medical records that the patient went on to receive a revision of the femoral component and head exchange with incision and debridement and placement of antibiotic beads.Updated 10-4-2017.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 48MM OD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; suzhou industrial park; warsaw IN 46582 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 6803910
• MDR Text Key: 83022617
• Report Number: 1818910-2017-23065
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032809
• UDI-Public: 10603295032809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2017

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: 136348000
• Device Lot Number: D17031948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 09/12/2017; 09/12/2017; 05/17/2018
• Supplement Dates FDA Received: 10/02/2017; 10/04/2017; 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 74