MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ10 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-12-180

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

Patient Problems Inflammation (1932); Pain (1994); Scar Tissue (2060); Discomfort (2330); Test Result (2695); No Code Available (3191)

Event Date 05/18/2011

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 pain and clicking.There was quite a bit of grayish tissue surrounding the capsule.Update ad 10 apr 2019.Receipt of medical records and sticker sheets.After review of medical records, the patient was revised to address pain, discomfort, symptoms of impingement, clicking sounds upon leg extension and elevated cobalt and chromium levels.Operative findings include a substantial amount of joint fluid extruded from the joint, inflammation and extensive scar tissue.Added medical history, expiration dates, patient date of birth, patient harms and product experience code for impingement, femoral sleeve and stem.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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 DUOFIX TAP SZ10 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: 8577836
• MDR Text Key: 143966464
• Report Number: 1818910-2019-92422
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060215
• UDI-Public: 10603295060215
• Combination Product (y/n): N
• PMA/PMN Number: K011489
• 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: 1570-12-180
• Device Catalogue Number: 157012180
• Device Lot Number: ZF4EM1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR