MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 45X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103545000

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

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 liner inside of bipolar head was abnormally loose.Surgeon noticed when putting femoral head in it and never implanted.Case wasn¿t delayed and implant being shipped back to office.Doe: (b)(6) 2019.Unknown affected side.

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 product problem is identified.Examination of the returned components finds they can be assembled with no excess or unexpected movement identified.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: null.Device history batch: null.Device history review: null.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 45X28 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
• MDR Report Key: 9290207
• MDR Text Key: 165436410
• Report Number: 1818910-2019-114733
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003359
• UDI-Public: 10603295003359
• Combination Product (y/n): N
• PMA/PMN Number: K812672
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103545000
• Device Lot Number: HK8017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention