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

Catalog Number 121730500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

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.Occupation: reporter is a non-healthcare professional.(b)(4).

Event Description

The patient was revised to address hip instability.Litigation alleges discomfort, injury, emotional distress, disability, disfigurement, partial or complete loss of mobility, and loss of range of motion.Doi: unknown; dor: (b)(6) 2018; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).(b)(4) use for surgical intervention.

Event Description

Ppf alleges dislocation, metal wear, metallosis and elevated metal ions.After review of medical records, patient was revised to addressed failure left total hip with instability and metal on metal bearing causing metal on metal debris.Revision notes indicated black fluid, took the head and liner out, took the screw that was there out and copious irrigation was performed.Added medical history, expiration date of head, date of birth and age of patient, product details and date of implant of screw.Also added stem due to alleged elevated metal ions.Doi: (b)(6) 2008; dor: (b)(6) 2018; left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.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.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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, h6(patient).Corrected: a4.

Event Description

Pfs alleges pain, nerve damage, walking difficulty, anxiety and fear.After review of medical records no new allegation reported.Corrected weight of patient.Doi: (b)(6) 2008 dor: (b)(6)2018 left hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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. .

• 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: 8599394
• MDR Text Key: 144691744
• Report Number: 1818910-2019-93133
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/18/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 121730500
• Device Lot Number: C4YKG4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/18/2019; 07/10/2019; 01/07/2020; 01/09/2020; 01/17/2020; 01/24/2020
• Supplement Dates FDA Received: 05/10/2019; 07/11/2019; 01/07/2020; 01/09/2020; 01/22/2020; 01/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 106