MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Model Number 1246-03-000

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 11/09/2020

Event Type  malfunction  

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 Description

After cup was impacted into the acetabulum, the surgeon asked for an apex hole eliminator.He inserted the hole eliminator into the cup and it went straight through the hole in the cup, and fell off the screwdriver behind the new acetabular cup.After telling me what had happened, he continued surgery as normal.There was a slight surgical delay.No additional information is available.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: APEX HOLE ELIM POSITIVE STOP
• Type of Device: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10875693
• MDR Text Key: 217358680
• Report Number: 1818910-2020-25107
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: 10603295019688
• Combination Product (y/n): N
• PMA/PMN Number: K963309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2020

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 Model Number: 1246-03-000
• Device Catalogue Number: 124603000
• Device Lot Number: D20091396
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 11/09/2020; 01/21/2021
• Supplement Dates FDA Received: 11/20/2020; 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINN 100 W/GRIPTION 48MM; APEX HOLE ELIM POSITIVE STOP; PINN 100 W/GRIPTION 48MM