MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HARDINGE FEM CEMENT RESTR; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Catalog Number 963203000

Device Problems Fracture (1260); Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

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

We had issue with some of these last week too.They don't fit on the introducer and are just shredding if you try to force them.Lot number:d19071266.Ref number: (b)(4).

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 was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: HARDINGE FEM CEMENT RESTR
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9586292
• MDR Text Key: 189087429
• Report Number: 1818910-2020-01688
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 963203000
• Device Lot Number: D19071266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1