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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); No Code Available (3191)
Event Date 08/28/2016
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. (b)(4).
 
Event Description
The literature article entitled, "failure rates of asian-type anatomic medullary locking stemmed metal-on-metal total hip replacement: a cause for adverse tissue reactions to metal debris (armd)" written by masaru nakamura, tateaki shimakawa, shunji nakano, takashi chikawa, shinji yoshioka, masahiro kashima, shunichi toki, hidehisa horiguchi, and koichi sairyo published by journal of orthopaedic science 21 (2016) 779e785 published only 28 august 2016 was reviewed for mdr reportability. The purpose of the article: " to examine the incident rate of armd, and the implant survival rate as well as to compare the armd group and non-armd group. " the article reports on 23 individual cases that received initial depuy product mom thrs between february 2007 and november 2009 of which 14 required revision due to reported pain suspected armd and 9 who did not receive revision but treated conservatively for unexplained hip pain and/or swelling. The non-revision cases had no particular findings, and symptoms subsided by conservative treatment of nonsteroidal anti-inflammatory drugs and anti-allergic agents. Each case is captured individually within linked complaints. All cases received aml-a plus stem, ultamet metal insert, ultamet head and pinnacle cup. All patients who received revision had bacterial culture inspections that were negative for infections but all were diagnosed with armd with note of debris including 13 of the 14 with deposition of metal debris at the head-neck junction. This complaint captures revision case 9 of a (b)(6) female with a r thr. The radiographic analysis reveal stem circumference osteolysis. She reported a hip click noise and incongruity (no further details of reasoning of incongruity) without note of edema 33 months post initial implantation and noted turbid milky white joint fluid color intraoperatively. Deposition of metal debris at the head-neck junction was noted as positive. Revision surgery changed bearing surfaces to mop and a stem exchange. Cross reference to narrative description indicates the stem was revised due to loosening.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> no device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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 NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9216695
MDR Text Key174218956
Report Number1818910-2019-110979
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
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 Received12/19/2019
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

Patient Treatment Data
Date Received: 10/21/2019 Patient Sequence Number: 1
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