MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-120

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

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Blood Loss (2597); Test Result (2695); No Code Available (3191)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.Additional follow up is being conducted to determine the initial reporter.If/when additional information is received, a supplemental 3500a will be submitted.(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

Unf and medical records received.Pinnacle claim submission form alleges elevated metal ions and infection.After review of medical records patient was revised to address metal on metal right hip arthroplasty with pinnacle cup and metal liner and summit stem with cobalt chrome head and infection reaction due to prosthetic device right tha.Revision notes reported that the cultures were obtained at this time.Anerobic aerobic afb and fungal and a gram stain.Doi: (b)(6) 2009, dor: (b)(6) 2019 (right hip).

Event Description

Additional information received stated that the patient presented with right hip pain in the groin area as well as in the trochanteric bursa region.During clinic visit on (b)(6) 2019.

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.Patient code: retracting code for hemorrhage and blood loss and replaced with pain.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10458693
• MDR Text Key: 204512902
• Report Number: 1818910-2020-18869
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060079
• UDI-Public: 10603295060079
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 1570-11-120
• Device Catalogue Number: 157011120
• Device Lot Number: D4ECM1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MULTIHOLE W/GRIPTION 54MM; PINNACLE MTL INS NEUT36IDX54OD
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 108