MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 32MM +9; FEMORAL HEAD

Catalog Number 136532730

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fever (1858); Nausea (1970); Pain (1994); Injury (2348); Hypoesthesia (2352); Joint Dislocation (2374); Not Applicable (3189)

Event Date 04/18/2017

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.

Event Description

Pfs and medical records received.Pfs alleges pain, injury, walking difficulty, numbness, balance issues, and two dislocations after the first revision surgery.After review of medical records for mdr reportability, it was stated that the patient had a second revision to address pain and dislocation.Patient had her first dislocation that was reduced the night prior to the second revision surgery.Revision notes also reported some bursal-type tissues present with some blood due to dislocation.The head and liner were the only products revised.Clinical notes reported fever and nausea.Doi: (b)(6) 2017; dor: (b)(6) 2017; right hip see (b)(4) for the first revision.See (b)(4) for the knee complaint.

Manufacturer Narrative

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 will be filed as appropriate.

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.  udi: (b)(4).Corrected: (dor).

• Brand Name: DLT TS CER HD 12/14 32MM +9
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7618659
• MDR Text Key: 111632673
• Report Number: 1818910-2018-62630
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033486
• UDI-Public: 10603295033486
• Combination Product (y/n): N
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2018

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: 09/30/2021
• Device Catalogue Number: 136532730
• Device Lot Number: 136532730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 10/30/2018; 03/03/2019
• Supplement Dates FDA Received: 10/31/2018; 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 81