MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 44X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-44-000

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 11/11/2021

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 due to hematoma/infection.Doi: (b)(6) 2021.Dor: (b)(6) 2021.Affected side: 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 : a review of the device manufacturing records (dhr) was performed as part of this investigation.A manufacturing record evaluation was performed for the finished device 103544000, lot j95t02, and no non-conformances / manufacturing irregularities related to the malfunction were identified.Should further information come available that impacts the findings in this investigation it will be reopened.

• Brand Name: SELF CENT HIP 44X28 GRY
• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12907792
• MDR Text Key: 281503756
• Report Number: 1818910-2021-26601
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003342
• UDI-Public: 10603295003342
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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: 1035-44-000
• Device Catalogue Number: 103544000
• Device Lot Number: J95T02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +8.5 BL; SELF CENT HIP 44X28 GRY
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 56 KG