• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 157011110
Device Problems Degraded; Biocompatibility
Event Date 09/06/2011
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). Attorney. (b)(4).

 
Event Description

Bilateral patient was implanted with a depuy asr hip implant on the left side on or about (b)(6) or (b)(6) 2006, and on his right side on or about (b)(6) 2007. Patient has experienced physical injury, pain, bodily impairment, and high levels of toxic metal in his blood stream. He believes he will be required to undergo revision surgery. 1/18/12 - plaintiff¿s preliminary disclosure form was received, which identified part/lot information and date of implant for the left side. Sticker sheets were also received, which indicate that patient was implanted with pinnacle products, not asr as previously mentioned for the right side. The complaint and associated mdrs were updated for the left side. Synovitis, cloudy fluid, trunnion staining, soft tissue scarring & ossification. Update: pfs alleges pseudotumor, metallosis, metal wear, abnormal gait when walking, and skin rash. After review of medical records, patient was revised to addressed pain and synovitis. Revision notes reported of pseudotumor, abundant amount of cloudy fluid, there was minimal trunnion staining, extensive soft tissue scarring and ectopic ossification.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSUMMIT POR TAPER SZ5 HI OFF
Type of DeviceSUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6103142063
MDR Report Key9328374
Report Number1818910-2019-116432
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number157011110
Device LOT NumberA55BF1000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/16/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/15/2019 Patient Sequence Number: 1
-
-