MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-11-110

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 08/07/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Patient was revised to address acetabular cup loosening and osteolysis.Update 02/12/2013 - litigation received 08/17/2012 alleges patient suffered severe past and future pain and suffering, disability, physical impairment, disfigurement, severe past and future emotional distress and mental ang.Update ad 10 apr 2019.(b)(4) is a reopen of wpc (b)(4) due to receipt of medical records and sticker sheets.After review of medical records, it was indicated that the patient was revised to address pain, elevated metal ion levels and changes in metal status.Revision notes reported some clear joint fluid with metal debris, scar tissue and heterotrophic bone formation.Although cup loosening was previously alleged, this was not indicated in the medical records.Doi: (b)(6) 2008; dor: (b)(6) 2012; (right hip).This complaint was updated on 23 apr 2019.

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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy 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.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 SZ5 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: 8577842
• MDR Text Key: 143968483
• Report Number: 1818910-2019-92412
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1570-11-110
• Device Catalogue Number: 157011110
• Device Lot Number: C4TKP1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR