MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX15MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121715500

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hematoma (1884); Dizziness (2194); Blood Loss (2597); No Code Available (3191)

Event Date 05/03/2019

Event Type  Injury  

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 total hip done and 5 days post op had a fall.The fall caused her cup to migrate into her pelvis.The pelvis was fractured quite badly and a full revision and reconstruction of her pelvis was required.Doi: (b)(6) 2019.Dor: (b)(6) 2019.Right hip.

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.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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 = 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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received indicating that on (b)(6) 2019, the patient was admitted to the critical care unit due to a fall with resulting pelvic fracture and acetabular cup migration.It is noted the patient was dizzy before falling.On (b)(6) 2019, the patient underwent a right hip revision due to a pelvic fracture and cup migration.The surgeon noted a fair amount of hematoma.The surgeon described the fracture as a severely comminuted acetabular fracture, anterior column was fractured, posterior column fractured, as was the inferior ring of the acetabulum, so the posterior wall and ischium were floating.There was severe comminution of the medial wall and again, the anterior wall was unstable as well.The pelvic fracture was corrected with a pelvic reconstruction plate and acetabular cage.The surgeon also reported the cup was malpositioned and the femoral head was out of the cup.The surgeon indicated the cup was completely flipped upside down.The patient loss an estimated 1000 ml of blood during the revision operation and received two units of packed red blood cells.However, the surgeon noted there were no intra-operative complications.

• Brand Name: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8635675
• MDR Text Key: 145915646
• Report Number: 1818910-2019-94378
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009306
• UDI-Public: 10603295009306
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121715500
• Device Lot Number: D18060809
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/21/2019; 07/01/2019
• Supplement Dates FDA Received: 06/25/2019; 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 91