MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-056

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

Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Thrombosis (2100); No Code Available (3191)

Event Date 09/08/2016

Event Type  Injury  

Manufacturer Narrative

(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

Pcf and medical records received.After review of medical records, the patient was revised for infected left hip.The patient presented with pain, his c-reactive protein went up to over 12.A repeat aspiration revealed frank pus, which grew staphylococcus.Operative notes reported that the hip bursa was entered and it was full of pus.The head and liner was removed.Doi: (b)(6) 2015 ; dor: (b)(6) 2016; left hip.Dvt, major bleed, and hypersensitivity were coded on cup, screw and stem due to allegations after 1st revision, which is captured on (b)(4).

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.

• Brand Name: PINNACLE SECTOR II CUP 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: 10568499
• MDR Text Key: 207983852
• Report Number: 1818910-2020-20698
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009849
• UDI-Public: 10603295009849
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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: 1217-22-056
• Device Catalogue Number: 121722056
• Device Lot Number: 622365
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX30MM; SUMMIT POR TAPER SZ6 HI OFF; ALTRX NEUT 36IDX56OD; ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX30MM; SUMMIT POR TAPER SZ6 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR