MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043 ARTICUL/EZE BALL 28 +8.5 BL; HIP FEMORAL HEAD

Catalog Number 136513000

Device Problem Material Separation (1562)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Patient was revised to address a dislocation.Update received 02/02/2016.Clinical report was received indicating a revision due to dislocation.Update received 02/05/2016.Additional clinical report was received stating that patient was also revised to address poly wear.Complaint was updated on 02/08/2016.Update received 02/15/2016, dated (b)(6) 2016.Additional clinical report was received.Diagnosis for previous hip surgery, activity level and comorbidities have been received.Complaint has been updated with this additional information.Complaint was updated on 02/15/2016.Update rec'd 03/04/2016 and 03/15/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records during an attempt at a closed reduction the patient's components dissociated.The patient was then revised.Upon revision the inner-outer diameter head ball bipolar component was dissociated leaving the larger outer diameter head ball dislocated superiorly with reduction of the smaller head ball into the acetabular socket.Also noted at revision the liner was deformed probably from repetitive subluxation episodes.At this time the patient's femoral head is being added to the complaint and reported.The complaint was updated on: 03/30/2016.

Manufacturer Narrative

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 combinations since release for distribution.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ARTICUL/EZE BALL 28 +8.5 BL
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5534714
• MDR Text Key: 41457367
• Report Number: 1818910-2016-16400
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK843909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

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: 12/31/2018
• Device Catalogue Number: 136513000
• Device Lot Number: D14011362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 100