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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT Back to Search Results
Catalog Number UNK HIP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Ischemia (1942); Renal Failure (2041); Thrombosis (2100)
Event Date 08/04/2013
Event Type  Injury  
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. (b)(4).
 
Event Description
The literature article entitled, "cemented or cementless tha in patients over 80 years with fracture neck of femur: a prospective comparative trial" written by a. S. Gavaskar, n. C. Tummala, and m. Sub mammalian published by musculoskeletal surg (2014) 98:205¿208 doi 10. 1007/s12306-013-0296-6 on 4 august 2013 was reviewed for mdr reportability. The article reports on patients greater than 80 years old who received tha between march 2006 and january 2009 with depuy implants. Group i consisted of 31 patients with cemented c-stem with ogee cup and group 2 consisted of 31 patients with cementless duraloc shell augmented with screws and a poly liner with collarless corail or summit stem. The femoral head was 28mm metal without indication of platform but suggestive towards depuy product. Nine total patients died with 3 in the perioperative period (all in group 1) with one dying during cementing process mid surgery and 6 unrelated to implants or procedure. Group i had the following results and complications that required interventions: 20 transfusions, 1 calcar intra-op associated to 1 dislocation due to subsidence attributed to calcar fracture who required revision, 1 acetabular aseptic loosening requiring revision. Group 1 also had noted complications without clarification of specific interventions provided: 1 etopic ossification, 1 dvt, 1 pe, 1 acute renal failure, 1 silent mi, 2 cardiac ischemia, and 1 pulmonary infection. Group 2 had the following results and complications that required interventions: 15 transfusions, 3 intra-op fractures treated with cerclage wiring, 2 dislocations with closed reductions and immobilizations. Group 2 also had noted complications without clarification of specific interventions provided: 1 dvt, 1 acute renal failure, 1 cardiac ischemia, and 1 pulmonary infection. The article does not identify product name of cement.
 
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Brand NameUNKNOWN HIP IMPLANT
Type of DeviceHIP IMPLANT
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 Key9174672
MDR Text Key173008164
Report Number1818910-2019-108128
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,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
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 Received12/06/2019
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: 10/10/2019 Patient Sequence Number: 1
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