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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Joint Dislocation (2374); No Code Available (3191)
Event Date 02/11/2015
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

Literature article entitled, "midterm results of delta ceramic-on-ceramic total hip arthroplasty. " literature article entitled, ¿midterm results of delta ceramic-on-ceramic total hip arthroplasty¿ by william g hamilton, md, et al, published by the journal of arthroplasty (2015), vol, 30, supplement 1, pp. 110-115 was reviewed for mdr reportability. From october 2003 to august 2007, a total of 345 hips were enrolled in two fda investigational device exemption (ide) delta ceramic-on-ceramic tha studies. Institutional review board (irb) approval was obtained at all sites. This study reports mid-term results of delta ceramic on ceramic (coc) in total hip arthroplasty (tha). Subjects received delta coc tha in a prospective multi-center study with either 28 mm (n=177) or 36mm(n=168) articulations. 168 subjects were enrolled in the coc36 arm between april 2006 and august 2007. All patients received a cementless porous coated acetabular cup (pinnacle) and one of five cementless femoral stems based on surgeon preference (aml, prodigy, summit porocoat or duofix, srom, or corail). The coc28 group received a ceramic bearing insert (ceramax) with a 28 mm inner diameter. The coc36 group received a ceramic bearing insert (ceramax) with a 36 mm inner diameter. All ceramic bearings and matching diameter femoral heads were biolox delta amc (ceramtec ag). Head-liner mismatch never occurred. Demographics and preoperative diagnoses were representative of a younger hip arthroplasty population. Comparing the coc28 and coc36 subjects, there was no difference in the harris hip scores at most recent follow-up. There were also no differences in the pain, functional, activity, deformity or range of motion components of the harris hip scores among the 28 and 36 coc groups. A total of 9 revisions were performed over the course of the study. There were 3 revisions performed for infection (2 in the coc28 and 1 in the coc36), 4 revisions for stem loosening (2 in the coc28, 2 in the coc36), and 2 revisions for liner fracture (1 in coc28, and 1 in coc 36). The dislocation rate in this series was 3. 4% (6/177) for the coc28 arm and 1. 8% (3/168) for the coc36 arm. Radiographic review showed no acetabular demarcation lines or interface gaps greater than 2 mm and no observations of cup migration, change in inclination angle, cup instability, or osteolysis for any subject at any time period. Among subjects who were not revised, 1 coc28 subject and 1 coc36 subject had femoral stem radiolucencies greater than 2mmat last follow-up (at 48 months for both subjects). There have been no femoral head fractures. There was a total of 3 post-operative ceramic liner fractures: 2 coc28 (2/168, 1. 2%) and 1 coc36 (1/168, 0. 6%). One of the coc28 liner fractures has been revised and was previously reported in (b)(4); there are no new coc28 liner fractures since that original report. At the time of this current review, the second coc28 post-operative liner fracture has not been revised at 7. 65-year follow-up because the patient was asymptomatic and refused revision. The coc36 post-operative liner fracture was revised at 20 months. The patient presented with hip ¿clicking¿ and radiographs showed that there had been a failure of the ceramic liner. The fractured ceramic liner was removed, and the acetabular cup was left in place. Examination of the explanted liner demonstrated evidence that the fracture was a result of component-to-component impingement. A total of 3 intra-operative ceramic liner fractures occurred in coc subjects: 2 coc28 (2/177, 1. 1%) that were previously described [30] and 1 coc36 (1/168, 0. 6%). All of these intra-operative liner fractures occurred when attempting to seat the liner. One subject received a replacement ceramic liner and was followed in the study, without any subsequent adverse events related to the bearing surface. There were 26 (26/345, 7. 5%) patients who reported hearing squeaking from their hip (7 in coc 28, 7/177, 4. 0%; 19 in coc36, 19/ 168, 11. 3%). All coc 28-mm components are previously reported in (b)(4). This is a companion to and comparison study of (b)(4). Only pes and patient consequences for the 36-mm ceramic components are reported within this complaint.

 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key9008170
MDR Text Key161960528
Report Number1818910-2019-104131
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/12/2019
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: 09/12/2019 Patient Sequence Number: 1
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