MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +0; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

Catalog Number 136310000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision hip: dr (b)(6), (b)(6) hospital (b)(6) 2018.Primary implant date: (b)(6) 2018.Revision for: infection - staph.Patient presented to theatre over the weekend of (b)(6) with infected hip.This was washed out and a vac/irrigation dressing applied.Was taken back to ot on tuesday (b)(6) for attempted revision for removal of head and replace with possible cement in cement revision of stem.At this time only a washout occurred again and vac dressing -(b)(4).Jnj representative on checking the upcoming revision date was told this had occurred last night ((b)(6) 2018) without rep present.Female patient id: (b)(6), aged (b)(6), dob: (b)(6).

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.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.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: TAPERED SPACER ARTICUL/EZE +0
• Type of Device: HEMI HIP IMPLANT : HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7780927
• MDR Text Key: 117134369
• Report Number: 1818910-2018-66565
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032670
• UDI-Public: 10603295032670
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

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 Catalogue Number: 136310000
• Device Lot Number: C86012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• 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: 71 YR