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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 Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)
Event Date 12/14/2010
Event Type  Injury  
Manufacturer Narrative

Product complaint # ==> (b)(4). If information is obtained that was not available for the initial medwatch.

 
Event Description

Literature article entitled, ¿early to mid-term results of ceramic-on-ceramic total hip replacement: analysis of bearing-surface-related complications¿ by g. H. Stafford, et al, published by the journal of bone and joint surgery (2011), vol. 93-b, pp. 1017-1020, was reviewed for mdr reportability. The purpose of this article was to determine the incidence of audible phenomena or other bearing-related complications. The authors reviewed a series of 224 cementless ceramic-on-ceramic thrs in 250 patients between april 2000 and december 2007 with a minimum follow-up of two years. There were 91 men and 145 women with a mean age of 44 years. Most patients had osteoarthritis, but a substantial proportion had inflammatory arthritis, in particular juvenile idiopathic arthritis. Depuy femoral components were the s-rom and corail stem (46 s-rom, 26 corail). Depuy acetabular components were the pinnacle and duraloc cup (99 duraloc, 45 pinnacle). The ceramic-bearing components were either biolox forte or biolox delta (123 28-mm forte, 79 32-mm forte, and 48 36-mm delta). The authors also used femoral and acetabular components manufactured by a competitor. The mean follow-up was 59 months. No patient reported squeaking of the hip, but six stated that there were occasional ¿grinding¿ or ¿crunching¿ noises, which were associated with movements involving deep flexion. One sometimes felt a grinding sensation when walking but could not provide greater detail. None of these hips were painful and the noises were noticed more than 12 months after index tha. None of the patients felt that they needed further treatment or investigation. Six patients have undergone revision, two for deep infection. One patient sustained a spontaneous fracture of a 28 mm biolox forte head with a short neck on a competitor stem; two patients were revised for recurrent dislocation secondary to impingement, one of whom had two episodes of posterior dislocation in close succession four years after the primary replacement. The acetabular component lacked anteversion resulting in impingement in flexion. The other patient developed recurrent anterior dislocation eight years after the primary thr as a result of impingement in extension and external rotation. A small notch in the posterior aspect of the femoral neck was noted on the radiographs where it was impinging against the acetabular component. One hip with a 32 mm biolox forte bearing was revised for recurrent clicking of the hip when it was extended, which the patient found troublesome. There was excessive anteversion of the acetabular component and the hip was revised two years after surgery. At revision, moderate metallosis involving the joint capsule with an associated effusion was found in all revised patients. Other complications included avulsion of the greater trochanter after a dislocation. No active treatment was required. Two patients had a dislocation but did not require revision. One patient sustained a vancouver type c peri-prosthetic fracture four years after index tha. This was treated by internal fixation retaining the original components. Radiological analysis showed no signs of osteolysis around either component in all 250 hips, or signs of migration or subsidence. The authors did not find any eccentrically located femoral heads and there were no signs of malalignment of the liner. In eight hips evidence of heterotopic bone formation was noted none of which exceeded brooker grade ii. The authors not that 3 hips requiring revision for recurrent dislocation had laxity due to the extensive effusion found in the joint capsule as a result of diffuse metallosis. The authors do not assign harms to specific products or patients within the text of the article.

 
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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)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
warsaw, PA 19380-0988
6107428552
MDR Report Key9141524
MDR Text Key166179735
Report Number1818910-2019-107060
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,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2019
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 Received10/07/2019
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: 10/01/2019 Patient Sequence Number: 1
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