MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121730500

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 09/17/2018

Event Type  Injury  

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.(b)(4).Occupation: attorney.

Event Description

Pfs and medical records received.Pfs alleges significant pain, loose cup and infection.After review of medical records, the patient was revised for failed left total hip arthroplasty and right knee arthritis.Operative finding identified grossly loose cup and frozen section revealed multiple areas consistent with periprosthetic joint infection.Patient was implanted with prostalacs and non-depuy components.The patient underwent an open reduction internal fixation on (b)(6) 2018 to repair her fractured femur due to fall.Doi: (b)(6) 2011 (stem); doi: (b)(6) 2017 (cup, liner, head, screws); dor: (b)(6) 2018; left 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).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9411329
• MDR Text Key: 169211350
• Report Number: 1818910-2019-120215
• Device Sequence Number: 1
• Product Code: NDJ
• UDI-Device Identifier: 10603295010159
• UDI-Public: 10603295010159
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121730500
• Device Lot Number: D15050424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 100