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

Model Number 1363-10-000

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 08/25/2020

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

It was reported as infected hip hemiarthroplasty.Incision and debridement and head/spacer exchange.No other information is available.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: right hip.

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.

• 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 46581 0988
• MDR Report Key: 10509792
• MDR Text Key: 206192894
• Report Number: 1818910-2020-19704
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 10603295032670
• UDI-Public: 10603295032670
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1363-10-000
• Device Catalogue Number: 136310000
• Device Lot Number: J5121M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR CATHCART BALL 53 MM OD.; TAPERED SPACER ARTICUL/EZE +0.; MODULAR CATHCART BALL 53 MM OD; TAPERED SPACER ARTICUL/EZE +0
• Patient Outcome(s): Required Intervention
• Patient Weight: 89