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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 Death (1802); Bone Fracture(s) (1870); Hemorrhage, Cerebral (1889); Unspecified Infection (1930)
Event Date 08/10/2010
Event Type  Death  
Manufacturer Narrative
Product complaint # (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
Mr number: (b)(4) admitted and operated in (b)(6) 2008. He had suffered lots of problems post hip implant, and expired on (b)(6) 2010. Possible asr hip reported for death, caused by cerebral hemorrhage, secondary to hypertension, with an unknown hip fracture. There was also a report of an infection, and that the patient may have been bed-ridden at the time of his death. Records provided suggest a possible but unconfirmed asr hip construct, with unknown side and unknown date of implantation. It is unclear within the records provided whether the hip was actually revised. It is unclear if the reported fractured hip was a result of depuy products, nor if infection was the consequence of depuy product implantation. Additional follow-up is underway to attempt to clarify unknown information.
 
Manufacturer Narrative
Product complaint : (b)(4). Investigation summary : no revision of the device has been reported and there was no allegation that the device was a contributor to this event. No explanted devices have been received in respect of this patient for analysis. If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation. 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.
 
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Brand NameUNKNOWN HIP IMPLANT
Type of DeviceHIP IMPLANT
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, IN 19380-0988
6103142063
MDR Report Key8025654
MDR Text Key125709125
Report Number1818910-2018-74080
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 10/31/2018 Patient Sequence Number: 1
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