MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CANCELLOUS BONE SCREW 6.5X25MM; BONE SCREWS AND PINS : SCREWS

Model Number 1172-25-000

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

Patient Problems Erosion (1750); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # : (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient from (b)(6), had called up and informed that he has undergone right hip replacement surgery in the year 2007 at (b)(6).He said that as he was having the pain and visited the doctor and the dr has suggested him to undergo a revision surgery because of some problem in the implant.Thus wants the revision surgery to done by the johnson & johnson company and wants an urgent call back for the same.

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.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.Corrective action was not indicated.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 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.H10 additional narrative: corrected:h6(device codes).Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANCELLOUS BONE SCREW 6.5X25MM
• 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: 8860134
• MDR Text Key: 175498423
• Report Number: 1818910-2019-100000
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295007616
• UDI-Public: 10603295007616
• Combination Product (y/n): N
• PMA/PMN Number: K970929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1172-25-000
• Device Catalogue Number: 117225000
• Device Lot Number: BR8A34000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR