MAUDE Adverse Event Report: J & J MEDICAL (SUZHOU) LTD. - REG. # 3006356043 ARTICUL/EZE BALL 28 +5 BR; HIP FEMORAL HEAD

Catalog Number 136512000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/21/2015

Event Type  Injury  

Event Description

Patient was revised to address a dislocation.

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).Complaint to part 803.22, depuy orthopaedics is providing the following information, as depuy orthopaedics did not manufacture, or import, the following device(s): manufacturer: (b)(4).Event: this was used in conjunction with depuy product in this patient.

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 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.Corrective action was not indicated.Depuy considers the investigation closed at this time.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 +5 BR
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): J & J MEDICAL (SUZHOU) LTD. - REG. # 3006356043; no.299 changyang st; suzhou industrial park; suzhou 21512 -6; CH 21512-6
• Manufacturer (Section G): J & J MEDICAL (SUZHOU) LTD. - REG. # 3006356043; no.299 changyang st; suzhou industrial park; suzhou 21512 -6; CH 21512-6
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4938918
• MDR Text Key: 21928905
• Report Number: 1818910-2015-26451
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK883460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2017
• Device Catalogue Number: 136512000
• Device Lot Number: D12021229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2012
• 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: 55 YR