MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX30MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121730500

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Litigation alleges friction and wear between the metal head and liner caused the release of toxic metal ions and particles into the patient's body resulting to injury, discomfort, soreness, disfigurement, mental anguish, suffering, emotional distress and inability to perform normal daily activities.Added patient harms, law firm and unknown stem due to alleged high metal ions.In addition to what was previously alleged, ppf alleges metallosis and pseudotumor.Der states that the surgeon wanted to swap out the metal liner and metal head.When trying to remove the metal liner he noticed cup was loose.There was a delay of about 30 mins do to removing the cup and putting in a new one.The reason for removal was because the patient was having pain.

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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX30MM
• 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: 8448445
• MDR Text Key: 139713459
• Report Number: 1818910-2019-88345
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295010159
• UDI-Public: 10603295010159
• Combination Product (y/n): N
• PMA/PMN Number: K082585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/05/2019

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 121730500
• Device Lot Number: 430070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR