MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX20MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121720500

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Necrosis (1971); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Ppf and medical records receive.Ppf alleged loosening of the cup, dislocation, and elevated metal ions.After review of the medical records, the patient was revised to address the loosening of acetabular component, soft tissue loss, metallosis, and dislocation.Operative note reported of massive soft tissue destruction and broken 2 screws.There was no lot number provided for the broken screws.Doi: (b)(6) 2012; dor: (b)(6) 2016 (right hip); fourth revision.

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 #
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> (b)(4).Investigation summary
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> 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.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 6.5MMX20MM
• 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: 9204250
• MDR Text Key: 173038368
• Report Number: 1818910-2019-108923
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009795
• UDI-Public: 10603295009795
• 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
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 121720500
• Device Lot Number: 442072
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR