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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ3 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ3 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 157011090
Device Problem No Apparent Adverse Event
Event Date 03/17/2017
Event Type  Injury  
Manufacturer Narrative

Product complaint # (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

Ppf alleges infection after first revision. (left hip).

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> no device associated with this report was received for examination. A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution. 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 NameSUMMIT POR TAPER SZ3 HI OFF
Type of DeviceSUMMIT HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-XXXX
6107428552
MDR Report Key8537235
Report Number1818910-2019-91238
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/19/2012
Device Catalogue Number157011090
Device LOT NumberBB6BB1000
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 Received05/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2007
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: 04/22/2019 Patient Sequence Number: 1
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