MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 42X28 RUST; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Model Number 1035-42-000

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Voluntary report received under mw5097267.It was reported that the patient suffered a subcapital fracture of her right hip.Bipolar hip placed in 2020.The bipolar hip assembly failed and was removed on 2020.It was replaced with another device.The second device failed and was replaced in 2020.Doi: (b)(6) 2020.Dor: (b)(6) 2020; affected side: right hip.

• Brand Name: SELF CENT HIP 42X28 RUST
• 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: 10992434
• MDR Text Key: 220945716
• Report Number: 1818910-2020-26813
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003328
• UDI-Public: 10603295003328
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1035-42-000
• Device Catalogue Number: 103542000
• Device Lot Number: HP7295
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M 28MM 1.5; ARTICULEZE M 28MM 1.5
• Patient Outcome(s): Required Intervention