MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-100

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

Patient Problems Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 record received.After review of medical record patient was revised to address failed left total hip arthroplasty.Revision notes stated that the fluid underneath was murky but not frank terrible metallosis.Femoral head and cup were removed.Patient has a slightly shorter preoperative leg length on the left.Prior to the revision patient has pain and elevated metal ion.Doi: (b)(6) 2008 - dor: (b)(6) 2020 (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.

• Brand Name: SUMMIT POR TAPER SZ4 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: 10614509
• MDR Text Key: 209423481
• Report Number: 1818910-2020-21414
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060055
• UDI-Public: 10603295060055
• 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: 09/18/2020

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 Expiration Date: 05/31/2018
• Device Model Number: 1570-11-100
• Device Catalogue Number: 157011100
• Device Lot Number: CS2FJ1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASR ACETABULAR CUPS 50.; ASR TAP SLV ADAP 12/14 -1.; ASR UNI FEMORAL IMPL SIZE 45.; ASR ACETABULAR CUPS 50; ASR TAP SLV ADAP 12/14 -1; ASR UNI FEMORAL IMPL SIZE 45
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 65