MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121730048

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

Patient Problem Not Applicable (3189)

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

While the surgical team was threading the cup to the impactor, the pinnacle cup was apparently fused to the impactor.Therefore it was impossible to remove the cup from the impactor.When doing so, the surgeon said he felt something break, probably the impactor.Patient status/ outcome / consequences --> no.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: corrected:h6(device codes) product complaint #
=
> (b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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 will be filed as appropriate.

• Brand Name: PINN MULTIHOLE W/GRIPTION 48MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9286863
• MDR Text Key: 165320295
• Report Number: 1818910-2019-114525
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009962
• UDI-Public: 10603295009962
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: 121730048
• Device Lot Number: J3404N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1