MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 51X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-51-000

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

Patient Problem Pain (1994)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

(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 that the patient had a hip fracture back in (b)(6) of 2016, where dr.(b)(6) performed a hemiarthroplasty.((b)(6) 2016) the patient has been successfully ambulating on hemi until recently.Due to some hip pain, dr.(b)(6) believed the patient would benefit from having their hemi converted to a total.The bipolar and 28mm head were removed, a competitor acetabular component was implanted, and our femoral head was used in the conversion.The surgeon found this conversion to be successful and the closing process began.Doi: (b)(6) 2016.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.Device history lot (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 51X28 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: 11163715
• MDR Text Key: 226612680
• Report Number: 1818910-2021-00965
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003410
• UDI-Public: 10603295003410
• 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: 12/29/2020

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 Model Number: 1035-51-000
• Device Catalogue Number: 103551000
• Device Lot Number: C35861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +5 BR; ARTICUL/EZE BALL 28 +5 BR
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR