MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TITANIUM ROOF PILE SCREW 45MM; BONE SCREWS AND PINS : SCREWS

Model Number	1011-06-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060)
Date of Event	08/06/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Pc was created to capture the event.(pg 2560) (b)(6) 2009 operative records indicate the patient received a left total hip revision due to significant scarring and gross infection.Acetabular cage and prostalac was removed and irrigation and debridement was performed.Doi: (b)(6) 2009.Dor: (b)(6) 2009.Left hip.
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TITANIUM ROOF PILE SCREW 45MM
• Common Device Name: 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14732249
• Report Number: 1818910-2022-11111
• Device Sequence Number: 5595832
• Product Code: JDJ
• UDI-Device Identifier: 10603295000372
• UDI-Public: 10603295000372
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K962007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2012
• Device Model Number: 1011-06-501
• Device Catalogue Number: 101106501
• Device Lot Number: WT2BH4005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2002
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female