MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX50MM; BONE SCREWS AND PINS : SCREWS

Model Number	SOUTHFIELD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Discomfort (2330); Injury (2348); Osteolysis (2377); No Code Available (3191)
Date of Event	02/08/2016
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Complaint description: patient was revised to address acute infection.Update feb 14, 2018: pinnacle litigation records received.In addition to what was previously alleged, litigation alleges that corrosion and friction wear had caused metal ion and particles to be released into the patient¿s blood and tissues and bone surrounding the implant resulting to injuries such as adverse local tissue reaction, pain, crunching or popping noises in the hips, standing and walking difficulties, hip fractures or dislocations, fatigue, tissue inflammation, necrosis, metallosis, limited mobility, and tissue and bone damage.The patient is also suffering from discomfort, emotional distress and other injuries caused by the failed hip implant.Added stem due to reported metal ion toxicity, fractures and corrosion.Added new associated contact.Doi: (b)(6) 2008; dor: (b)(6) 2016 ; right hip this complaint was updated on: february 21, 2018.Patient is bilateral, see (b)(4) for the left hip.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX50MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9146470
• Report Number: 1818910-2019-107298
• Device Sequence Number: 2623490
• Product Code: LPH
• UDI-Device Identifier: 10603295010418
• UDI-Public: 10603295010418
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2016

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 Model Number: SOUTHFIELD
• Device Catalogue Number: 121750500
• Device Lot Number: WY7AR1123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR