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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP IMPLANT

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK HIP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 11/20/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle litigation records received.Litigation alleges difficulty walking, pain, discomfort, complete loss of mobility, injury, loss of range of motion and mental anguish.Doi: (b)(6) 2009; dor: (b)(6) 2017; right hip.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP IMPLANT
Type of Device
HIP IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8700738
MDR Text Key148055308
Report Number1818910-2019-96027
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/08/2018
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
Device Operator Health Professional
Device Catalogue NumberUNK HIP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/27/2019
Initial Date FDA Received06/14/2019
Supplement Dates Manufacturer Received07/02/2019
Supplement Dates FDA Received07/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight90
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