MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 53X28 BLU; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number	1035-53-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.T complaint # (b)(4).
Event or Problem Description
It was reported that the surgeon explained the patient was feeling some discomfort in their right hip.She believed it to be due to the wearing of the bipolar component on the patient's native acetabulum.The surgeon believed it would be best to convert this patient's bipolar into a total hip.The bipolar component and 28mm head were removed, allowing ample room for the surgeon to ream out the acetabulum.After reaming the acetabulum, a 54mm gription multi hole cup was implanted.A trial reduction was performed after implanting a 54x36mm +4 10 degree liner.The patient had lost some length, so a +15.5 was trialed and found to be satisfactory.The real head was opened and implanted.The hip was reduced and found to be stable.The closing process began.Doi: (b)(6) 2019, dor: (b)(6) 2020, right hip.
Additional 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 : per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain/discomfort.

• Brand Name: SELF CENT HIP 53X28 BLU
• Common Device Name: 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: 11116621
• Report Number: 1818910-2021-00166
• Device Sequence Number: 3698917
• Product Code: KWY
• UDI-Device Identifier: 10603295003434
• UDI-Public: 10603295003434
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K812672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1035-53-000
• Device Catalogue Number: 103553000
• Device Lot Number: J50Z91
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 53X28 BLU; ARTICUL/EZE BALL 28 +1.5 GR; SELF CENT HIP 53X28 BLU
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR