MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TITANIUM ROOF PILE SCREW 30MM; BONE SCREWS AND PINS : SCREWS

Model Number 1011-03-501

Device Problem Osseointegration Problem (3003)

Patient Problems Pain (1994); Tissue Damage (2104); Discomfort (2330); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/15/2014

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

Ppf alleges constrained liner, metallosis and loosening of cup.Doi: (b)(6) 2008 - dor: (b)(6) 2013 (right hip).

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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Pfs alleges limited mobility.

• Brand Name: TITANIUM ROOF PILE SCREW 30MM
• 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8435632
• MDR Text Key: 139296564
• Report Number: 1818910-2019-87808
• Device Sequence Number: 1
• Product Code: JDJ
• UDI-Device Identifier: 10603295000341
• UDI-Public: 10603295000341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 1011-03-501
• Device Catalogue Number: 101103501
• Device Lot Number: CK7JS4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 04/22/2019; 02/13/2020
• Supplement Dates FDA Received: 05/14/2019; 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2008
• 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: 67 YR
• Patient Weight: 108