MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157001080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	05/28/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Details w.R.T asr hip implant: first left leg total hip replacement was done on (b)(6) 2006 at (b)(6) and implant used was of depuy ref: (b)(4), lot: 2155140.First revision total hip replacement was performed on (b)(6) 2014 at (b)(6) and implant used was of depuy and left leg shortened by 5cm.Due to dislocation of implant second reverse thr done on (b)(6) 2014 at (b)(6).As severe infection and watery discharge from operated area again she underwent removal of thr implant, debridement and antibiotic spacer insertion on (b)(6) 2015 at (b)(6).Again infection and watery discharge from operated area she was admitted and surgery done on (b)(6) 2016 revision left thr for infection at (b)(6).Due to continuous pressure on right leg her knee of right leg pain started and knee replacement had to be done on (b)(6) 2018.As of now she is bedridden mentally disturbed and dependent physically and mentally on all family members for all day to day work.
Additional 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: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ2 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8816241
• Report Number: 1818910-2019-99034
• Device Sequence Number: 3027640
• Product Code: LPH
• UDI-Device Identifier: 10603295059332
• UDI-Public: 10603295059332
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 157001080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CREATED IN ERROR; CREATED IN ERROR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR