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

Model Number 1570-01-120

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

Patient Problems Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); Anxiety (2328); Foreign Body In Patient (2687); Fibrosis (3167); No Code Available (3191)

Event Date 02/05/2018

Event Type  Injury  

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 Description

Asr medical records received.After review of medical record, the patient was revised to address metallosis due to failed left total hip replacement.Operative note reported a lot of gray-colored synovial fluid, fair amount of deep red-gray synovial tissue, and there was metallosis around the trunnion.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.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.

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: SUMMIT POR TAPER SZ6 STD 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: 9682725
• MDR Text Key: 178201391
• Report Number: 1818910-2020-04300
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: 10603295059370
• UDI-Public: 10603295059370
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

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: No Information
• Device Expiration Date: 07/01/2018
• Device Model Number: 1570-01-120
• Device Catalogue Number: 157001120
• Device Lot Number: C1XA51000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 07/14/2020
• Supplement Dates FDA Received: 03/05/2020; 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR 300 SPIKED CUP SIZE 52; ASR UNI FEMORAL IMPL SIZE 46
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 70