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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER METAL
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Joint Dislocation (2374); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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
The literature article entitled, "mid-term progressive loosening of hydroxyapatite-coated femoral stems paired with a metal-on-metal bearing" written by trevor gascoyne, bryan flynn, thomas turgeon, and colin burnell published by journal of orthopaedic surgery and research (2019) was reviewed. The article's purpose was to examine possible causes and associated risk factors for mid-term (3-7 years post-surgery) aseptic loosening of ha-coated femoral stems and to detail their clinical manifestation through radiographic and implant retrieval analysis. Data was compiled from 46 retrieved depuy corail stems (retrieved implants revised between 2007 and 2015) - 14 standard and 32 collard designs. Three study groups created based on bearing material: mom (qty 10); mop (qty 24) and coc (qty 12). The article later identifies the bearing surfaces to be pinnacle mom for the mom group. Results were aseptic loosening of stem associated more with mom bearing surfaces and removal of proximal ha coating was strongly associated with taper corrosion score. Article reports head size, head offset, collared stem, and patient age were not associated with aseptic loosening. Figure 1 provides radiographic imaging of a loose stem. Figure 2 provides photographic images of explanted stem with taper corrosion. Depuy product: corail stem, pinnacle cup, pinnacle metal liner, metal femoral head (assumed to be depuy utilized with pinnacle liner). Adverse events: figure 2 identifies taper corrosion on stem. Revision for aseptic loosening of stem (qty 17). Revision for infection (qty 13). Revision for high metal ions (qty 1) - associated with mom wear. Revision for periprosthetic femoral fracture (qty 13). Revision for instability/malposition (qty 1) - no further information provided. Revision for dislocation (qty 1) - not associated with stem.
 
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Brand NameUNK HIP ACETABULAR LINER METAL PINNACLE
Type of DeviceMETAL ACETABULAR LINER
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
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key11055644
MDR Text Key225731017
Report Number1818910-2020-27443
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HIP ACETABULAR LINER METAL
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 Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2020 Patient Sequence Number: 1
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