MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX15MM; BONE SCREWS AND PINS : SCREWS

Model Number 1217-15-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Myocardial Infarction (1969); Pain (1994); Rash (2033); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

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

Pinnacle mom litigation records received alleging that the friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the plaintiff's blood and tissue and bone surrounding the implant leading to severe and chronic pain, discomfort, inflammation, injury, partial or complete loss of mobility and loss of range of motion.Also allegedly there is metallosis, heart attack and stroke, walking difficulty, and rash.Doi: (b)(6) 2007 - dor: to be revised (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.H10 additional narrative:.

• Brand Name: PINN CAN BONE SCREW 6.5MMX15MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10178725
• MDR Text Key: 195918334
• Report Number: 1818910-2020-14237
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295009306
• UDI-Public: 10603295009306
• Combination Product (y/n): N
• PMA/PMN Number: K983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

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 Model Number: 1217-15-500
• Device Catalogue Number: 121715500
• Device Lot Number: BY3KV4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; PINNACLE SECTOR II CUP 54MM; SUMMIT DUOFIX TAP SZ5 HI OFF; ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX54OD; PINNACLE SECTOR II CUP 54MM; PINNACLE SECTOR II CUP 54MM; SUMMIT DUOFIX TAP SZ5 HI OFF
• Patient Outcome(s): Required Intervention