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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
Event Date 09/24/2013
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, ¿early surveillance of ceramic-on-metal total hip arthroplasty¿ by j. C. Hill, et al, published by the bone and joint journal (2015), vol. 97-b, pp. 300-305, was reviewed for mdr reportability. This study reports a single surgeon series of com thas, with outcomes including implant survival, radiological outcomes, blood ion levels, and clinical outcomes including pain and patient-reported outcome measures (proms). A total of 287 com thas (271 patients) were performed under the care of the senior author (deb) between october 2007 and october 2009. In all cases, a corail femoral stem was used with a biolox delta ceramic head, and a pinnacle metal liner (all depuy). 28 mm, 32 mm and 36 mm diameter modular heads were used; all were available with three lengths of neck (1. 5 mm, 5 mm, 8. 5 mm). The mean follow-up time for the surveillance review was 34 months. At this time, three patients (four hips) had died, and two (two hips) had been lost to follow-up. Three patients (three hips) were unable to attend and were reviewed by telephone; these did not have radiographs or metal ion measurements. As a result, 281 hips (266 patients) were reviewed, of which 278 hips (263 patients) had radiographs and metal ion measurements. Six patients (2%) complained of noise (clicking, grinding or juddering) from the hip. As of august 2014, eight patients (eight thas) have undergone a revision due to pain. Two further patients were offered revision as the first had a pseudotumor surrounding the greater trochanter and the second showed radiographic changes in zones 1, 7, 8 and 14, as well as experiencing pain. Neither, however, underwent the procedure. One was considered too high risk for anesthesia and the other refused surgery as his symptoms were tolerable despite the identification of a pseudotumor on mri. The median blood levels of cobalt and chromium in all 263 patients (278 thas) were 0. 83¿g/l (0. 24 to 27. 56) and 0. 78¿g/l (0. 21 to 8. 84), respectively. A total of 31 patients (12. 5%, 35 thas) had blood cobalt levels of > 2 ¿g/l, and six patients had levels of > 7 ¿g/l (2. 5%, seven thas). For chromium, 26 patients (11. 1%, 31 thas) had levels of > 2 ¿g/l, and one patient (0. 4%, one tha) had levels of > 7¿g/l. The authors identify 8 patients and reasons for revision on table ii. These patients are included within the spreadsheet labeled case 1- case 8. Please link to parent (b)(4). Impacted products: pinnacle cup and liner, biolox ceramic head, corail femoral stem. Revised acetabular components 55 months after index tha due to implant noise reported as "juddering" and pain. Co 5. 4 ppb, cr 2. 6 ppb. Fluid collection within the joint capsule confirmed intraoperatively.

 
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Brand NameUNKNOWN HIP ACETABULAR LINERS
Type of DeviceHIP ACETABULAR LINERS
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
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9149317
MDR Text Key167562641
Report Number1818910-2019-107148
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUK
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 09/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP ACETABULAR LINER
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 Received09/26/2019
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: 10/02/2019 Patient Sequence Number: 1
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