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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); Noise, Audible (3273)
Patient Problems Cyst(s) (1800); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Osteolysis (2377); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Event Date 12/04/2020
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 entitled "pseudotumor and repeated dislocation after total hip arthroplasty with ceramic-on-metal bearing: a case report" written by yin-qiao du, tao luo, jing-yang sun, hai-yang ma, ming ni, and yong-gang zhou. Published by annals of palliative medicine published online/accepted by publisher 15 jul 2020 was reviewed. The article's purpose was to follow the case of a (b)(6) year-old female who underwent multiple revisions and manual reductions involving ceramic-on-metal hip products. The original primary operation occurred in december 2009 involving a cementless pinnacle cup and s-rom stem. Radiographic and intra-operative images can be found on pages 3 and 4 of the literature article. Depuy products with known adverse event(s): femoral head x 2, femoral stem, femoral cone, acetabular cup, acetabular screws x 2, acetabular liner. Adverse events: first revision with femoral head exchange to address pain, instability, difficulty walking, and noise. Subsequent multiple manual reductions to address dislocations leading to an eventual head, liner, and acetabular screw x 2 revision to address pain, fall, decreased range of motion, pseudotumor, cyst, edema, osteolysis, necrosis, inflammation, bone injury, and liner metal wear as well a placement of a cable system to address a femoral bone fracture.
 
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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 46581-0988
6107428552
MDR Report Key12688510
MDR Text Key279006769
Report Number1818910-2021-23398
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
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
Date Manufacturer Received12/15/2021
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: 10/25/2021 Patient Sequence Number: 1
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