MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CONTROL CABLE W/CABLE SLEEVE; HIP MISCELLANEOUS : CABLE/WIRE

Model Number 1739-28-000

Device Problems Device Slipped (1584); Unintended Movement (3026)

Patient Problems Cyst(s) (1800); Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Litigation papers allege the patient suffered pain and excessive chromium and cobalt blood levels.Update rec'd 03/31/2015 - plaintiff¿s preliminary disclosure form was received, which identified part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: 4/15/15.Update ad 31 dec 2019: (b)(4) has been re-opened under (b)(4) due to asr medical records received.After review of medical records the patient was revised to address mom reaction with formation of large pseudo-cyst resulting to pain and swelling.Operative note reported leg length discrepancy, pseudo-cyst was noted, fluid was slightly orange tinged but clear.A lot of fibrinous and tan colored debris collected.Minimal corrosion of the trunion.One of the cable was loose and was removed.There was large osteophyte posterior aspect of the acetabulum.Added revision date, srom stem due to mild corrosion.A depuy cable was reported since it was loose, revision surgeon name, medical history and age of the patient.Corrected patient identifier doi: (b)(6) 2007; dor: (b)(6) 2016 (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONTROL CABLE W/CABLE SLEEVE
• Type of Device: HIP MISCELLANEOUS : CABLE/WIRE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9627490
• MDR Text Key: 189003577
• Report Number: 1818910-2020-02795
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 10603295067788
• UDI-Public: 10603295067788
• Combination Product (y/n): N
• PMA/PMN Number: K934557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/02/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1739-28-000
• Device Catalogue Number: 173928000
• Device Lot Number: B1WBG1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR