MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 49X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-49-000

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

Patient Problem Pain (1994)

Event Date 06/02/2021

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

The patient was revised to address painful hip.Converted from a hemi hip to a total hip.No further information is available.Doi: (b)(6) 2020; dor: (b)(6) 2021; left 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.Device history lot: for allegations of pain a device manufacturing (mre) review will not be performed even when product/lot information is known.Per (b)(4), review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain.

• Brand Name: SELF CENT HIP 49X28 BRN
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11992495
• MDR Text Key: 255977434
• Report Number: 1818910-2021-12551
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003397
• UDI-Public: 10603295003397
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1035-49-000
• Device Catalogue Number: 103549000
• Device Lot Number: J61G87
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +5 BR; SELF CENT HIP 49X28 BRN; ARTICUL/EZE BALL 28 +5 BR; SELF CENT HIP 49X28 BRN
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR