MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CANCELLOUS BONE SCREW 6.5X15MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 117215000

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Inadequate Osseointegration (2646)

Event Date 02/08/2018

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 reported implants were implanted to the patient on (b)(6) 2004.It was reported that the revision surgery was performed on (b)(6) 2018 due to the loosening of the cup and polyethylene part was worn down.No further information was provided by the hospital.Doi: (b)(6) 2004; dor: (b)(6) 2018; unknown affected side.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.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: CANCELLOUS BONE SCREW 6.5X15MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0998
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0998 ; 5743725905
• MDR Report Key: 7316800
• MDR Text Key: 101607192
• Report Number: 1818910-2018-54609
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295007593
• UDI-Public: 10603295007593
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 117215000
• Device Lot Number: X44CE4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Date Device Manufactured: 10/17/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR