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

Catalog Number 103542000

Device Problem Fitting Problem (2183)

Patient Problem Not Applicable (3189)

Event Date 11/23/2018

Event Type  malfunction  

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

It was reported that the patient had a femoral neck fracture and needed a hemi arthroplasty to repair.After successfully trailing components and then inserting the real femoral stem, a 42mm bipolar head and 28mm +5 metal head were opened for implantation.After carefully removing the plastic portion from the 42mm shell, the 28 mm metal head was inserted into the plastic, but did not spin freely but only under significant force.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device history lot: h56827.Device history batch: null.Device history review: no anomalies or deviations were found during the review.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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 46582 0988
• MDR Report Key: 8178859
• MDR Text Key: 130821986
• Report Number: 1818910-2018-78646
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003328
• UDI-Public: 10603295003328
• Combination Product (y/n): N
• 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: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103542000
• Device Lot Number: H56827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 94 YR