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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Fracture; Loss of Osseointegration
Event Date 09/19/2009
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.

 
Event Description

Literature article received entitled "tha with delta ceramic on ceramic". Literature article entitled, "tha with delta ceramic on ceramic: results of a multicenter investigational device exemption trial" by william g hamilton, md, et al, published in clinical orthopedic related research (19 september 2009) vol. 468, pp. 358-366 was reviewed for mdr reportability. This article reports the early outcomes and complications of a prospective, randomized, multicenter trial of 264 hips at eight centers, comparing 177 delta coc hip articulations with 87 delta cop hip articulations with a minimum of 2 year follow-up. The coc group was implanted with a biolox delta ceramic liner and the cop group was implanted with a marathon polyethylene liner. All patients received the same biolox delta ceramic alumina composite femoral head size 28-mm and pinnacle acetabular cup. Patients received on of five depuy cementless femoral stems: aml, prodigy, corail, summit, or s-rom. The hhs and clinical, radiological, and survivorship outcomes were similar in both groups. In the coc group, there were 4 revisions: 1 for component dislocation and 2 for femoral component loosening, and one for postoperative ceramic liner fracture and infection. There were 3 intraoperative ceramic liner fractures with one fracture that required the removal of and reinsertion of a new acetabular cup to ensure the complete removal of all ceramic liner debris. There is one patient with a ceramic liner fracture who is scheduled for a future revision surgery. The coc group had the following complications in addition to the 4 revisions: 5 intraoperative femur fractures, 2 cases of deep infection, 1 case of nerve damage, 3 additional cases of dislocation, 1 additional case of femoral component loosening, and 9 incidences of wound problems. In the cop group, there were two revision surgery due to dislocation of the acetabular articulations. The cop group had in incidence of intraoperative femur fracture, 2 cases of intraoperative chipped liners, 2 additional dislocations, and two incidences of wound problems. There were no reports of acetabular loosening of the cup or osteolysis in either group. This study did not differentiate products in relation to patient harms in greater detail than listed in the above event description. The impacted products and associated harms are listed within the text on table 4 pp. 362. This study was part of a usfda investigational device exemption study (fda/ide).

 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP 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 19380-0988
6103142063
MDR Report Key8977162
Report Number1818910-2019-103634
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received10/11/2019
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: 09/09/2019 Patient Sequence Number: 1
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