MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-056

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

Patient Problems Stroke/CVA (1770); Chest Pain (1776); Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Visual Impairment (2138); Discomfort (2330); Osteolysis (2377); Vascular Dissection (3160); No Code Available (3191)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was revised to address pain from metal on metal hip.Metallosis was discovered during surgery.Litigation alleges injury, pain, blood heavy metal ions, emotional trauma and distress.In addition to what was previously alleged, ppf alleges pseudotumor.It was indicated that the patient had complaints of chest pain, stroke, type a aortic dissection, coma, additional stroke events, significant visual changes and lost peripheral vision in the left eye.It was also indicated that the ct scan shows area of osteolysis behind the cup including the medial wall of the left acetabulum suggesting particle disease.Patient also having minimal discomfort.Doi: (b)(6) 2009, dor: (b)(6) 2018, (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Examination of the provided x-ray images finds nothing indicative of a product problem.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINN SECTOR W/GRIPTION 56MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9746272
• MDR Text Key: 184810869
• Report Number: 1818910-2020-05779
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295010326
• UDI-Public: 10603295010326
• Combination Product (y/n): N
• PMA/PMN Number: K071784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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: 1217-32-056
• Device Catalogue Number: 121732056
• Device Lot Number: D3VET1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 109