MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CANCELLOUS BONE SCREW 6.5X35MM; BONE SCREWS AND PINS : SCREWS

Model Number 1172-35-000

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 01/13/2020

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.

Manufacturer Narrative

(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 to address pain and loosening of the cup at the bone to implant interface.Doi: (b)(6) 2000; dor: (b)(6) 2020; right hip.

• Brand Name: CANCELLOUS BONE SCREW 6.5X35MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9629214
• MDR Text Key: 184725123
• Report Number: 1818910-2020-02920
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295007630
• UDI-Public: 10603295007630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1172-35-000
• Device Catalogue Number: 117235000
• Device Lot Number: TV2KS1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/1999
• 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: 76 YR