MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-090

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

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Weakness (2145); Hypoesthesia (2352); Test Result (2695); No Code Available (3191)

Event Date 06/03/2015

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

Complaint description: patient was revised due to pain.Update ad 03 dec 2018: (b)(4) has been re-opened due to pfs and medical record received.Pfs alleges pain, popping, crunching, numbness, walking difficulty, metallic taste in the mouth, headaches and metal poisoning.After review of medical records the patient was revised to address elevated metal ion levels and leg length discrepancy, scarring, weakness and walking difficulty.Operative note reported soft tissues were stiff, anterior medius was not healed fully, partial tear or incomplete repair.There was fatty atrophy in the quadratus femoris.Abductor repair of the tissue.Doi: (b)(6) 2007.Dor: (b)(6) 2015.(left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.

• Brand Name: SUMMIT POR TAPER SZ3 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: 9371155
• MDR Text Key: 185083880
• Report Number: 1818910-2019-117884
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060048
• UDI-Public: 10603295060048
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 1570-11-090
• Device Catalogue Number: 157011090
• Device Lot Number: BF1BR1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 104