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

Catalog Number 121730500

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094); Tissue Damage (2104); No Code Available (3191)

Event Date 12/19/2018

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

The patient was revised due to metallosis.Screws were left proud on previous surgery.The surgeon believes that was the reason for metallosis.Head, liner, cup, hole eliminator, and 2 screws were extracted.

Manufacturer Narrative

(b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.(b)(4).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.

Event Description

(b)(6) has no new allegation.After review of medical records, patient was revised to addressed painful left hip, vertical appearing left acetabular component, synovitis with grayish yellow proliferation consistent with metallosis.Revision notes indicated upon entering the bursa there was an exuberant amount of yellow tinged fluid with particulate debris and some grayish yellow inflammation and proliferation on the inner surface of the bursa that was contiguous with hip joint but was negative for infection.Upon examining head and the trunnion there is evidence of black corrosion on both the trunnion and inside the femoral head component.There was black corrosion debris on the acetabular component as well as the metal liner.No evidence of black debris in screws but a little tiny less than 1 mm notch in the metal liner.Added law firm, lawyer, surgeon, date of implant, medical history, demographic data of patient, product details of liner, head, cup, apex hole eliminator, screws.Also added stem due to new allegation.Corrected patient's initial.Doi: (b)(6) 2009, dor: (b)(6) 2018 left hip.(b)(6).

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 caused or contributed to the potential event described in this report.Udi: (b)(4).No code available use for medical device removal.

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.

• 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 46582 0988
• MDR Report Key: 8249517
• MDR Text Key: 133111954
• Report Number: 1818910-2019-80998
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K9863014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 121730500
• Device Lot Number: DW1A64000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100