MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-32-062

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

Patient Problems Foreign Body Reaction (1868); Fluid Discharge (2686); Unspecified Tissue Injury (4559)

Event Date 02/09/2021

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

Medical records received.After review of medical records, it was reported that the patient had a draining of surgical wound procedure with extensive soft tissue necrosis secondary to metallosis from previous explanted metal on metal tha.Operative note reported that, upon entering the wound there was noted to be extensive soft tissue necrosis with a incomplete fascia layer.Some of the necrosis extended into the subcutaneous tissues.The proximal vastus lateralis was identified, this too appeared necrotic.Doi: (b)(6) 2007 (cup, screw, stem), doi: (b)(6) 2021 (head, liner), doe: (b)(6) 2021, 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.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 62MM
• 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: 12089133
• MDR Text Key: 259150165
• Report Number: 1818910-2021-13845
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010357
• UDI-Public: 10603295010357
• Combination Product (y/n): N
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1217-32-062
• Device Catalogue Number: 121732062
• Device Lot Number: B5KDX1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 LAT COXA VARA SIZE 15; DUAL MOBILITY HEAD; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 62MM; UNK HIP ACETABULAR LINER METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR