MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TAPERED SPACER ARTICUL/EZE +5; HEMI HIP IMPLANT : HIP FEMORAL AUGMENT

Catalog Number 136312000

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 02/25/2019

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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

The patient was revised to address painful socket.Doi: (b)(6) 2015; dor: (b)(6) 2019, left hip.

Manufacturer Narrative

Correction: (b)(4) under (b)(4) was being retracted because it was further identified that the event was due to natural progression.Thus, changed in reportability status from serious injury to not reportable.

• Brand Name: TAPERED SPACER ARTICUL/EZE +5
• Type of Device: HEMI HIP IMPLANT : HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8425402
• MDR Text Key: 138952116
• Report Number: 1818910-2019-87453
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032687
• UDI-Public: 10603295032687
• Combination Product (y/n): N
• PMA/PMN Number: K903084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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: 136312000
• Device Lot Number: 611269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention