MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX40MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 121740500

Device Problems Loss of Osseointegration (2408); Failure to Advance (2524); Difficult to Advance (2920); Osseointegration Problem (3003)

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Discomfort (2330); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Litigation alleges acetabular cup loosened or disconnected and released metallic debris into the patient¿s body resulting to excessive metal ion levels, severe pain, walking difficulty and other injuries.Doi: (b)(6) 2006; dor: (b)(6) 2016; right hip.This complaint was updated on: mar 29, 2018.

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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX40MM
• 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 ; 1210 ward avenue; west chester, PA 46581-0988 ; 6107428552
• MDR Report Key: 9287861
• MDR Text Key: 167348388
• Report Number: 1818910-2019-114575
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295010395
• UDI-Public: 10603295010395
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121740500
• Device Lot Number: ZS5GG4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2005
• 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