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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient had a bipolar mod endo inserted on (b)(6) 2020.On (b)(6) 2020 an x-ray showed that it had dislocated.So the doctor did a revision hip surgery on (b)(6) 2020.Upon revision surgery it was noted that the mod endo plastic was broken.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A review of a provided x-ray image and photograph of the explanted device finds sufficient evidence to confirm the reported problem.It was not possible to determine a root cause using the images.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 : lot hp7295.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: SELF CENT HIP 42X28 RUST
• 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: 10568098
• Report Number: 1818910-2020-20680
• Device Sequence Number: 2880765
• Product Code: KWY
• UDI-Device Identifier: 10603295003328
• UDI-Public: 10603295003328
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1035-42-000
• Device Catalogue Number: 103542000
• Device Lot Number: HP7295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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: ARTICULEZE M 28MM 1.5; ARTICULEZE M 28MM 1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75