• 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
Model Number 1570-11-110
Device Problems Biocompatibility; Naturally Worn
Event Date 01/18/2012
Event Type  Injury  
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. Occupation: attorney. (b)(4).

 
Event Description

Update 25 sep 018 (b)(4) has been re-opened under (b)(4) due to receipt of pfs and medical records. Pfs alleges pseudotumor, metallosis, metal wear and abnormal gait when walking. After review of medical records, patient was revised to addressed painful right hip, metal wear and elevated metal ions. Operative findings reported of synovitis , weakness and metal wear. Revision notes reported of trunnion wear and bursitis present on femoral head neck junction. It was also indicated that cup was also revised since the liner would not dis-impact from the cup. Added account name, law firm, lawyer, age of patient, gtin, stem due to trunnion and date of revision. Corrected patient's initial. Doi: (b)(6) 2007; dor: (b)(6) 2016; right hip.

 
Manufacturer 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, a follow-up medwatch will be filed as appropriate.

 
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
6107428552
MDR Report Key9328569
Report Number1818910-2019-116450
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 MODEL Number1570-11-110
Device Catalogue Number157011110
Device LOT NumberB4DE61000
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 Received01/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2007
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
-
-