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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-352
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Foreign Body Reaction (1868); Joint Dislocation (2374); Osteolysis (2377)
Event Date 03/15/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Patient underwent primary total hip replacement approximately 10 years ago. At this stage a corail stem with metal on metal pinnacle shell was utilised. Patient has been doing relatively well but had a sudden dislocation approximately 6 months ago. X rays indicate osteolysis, especially behind the acetabular component. On opening the hip ((b)(6) hospital, (b)(6) 2022), metalosis was evident in the soft tissue surrounding the hip - presenting as black stained tissue. The pinnacle shell was removed and extensive metalosis/ osteolysis was found behind the shell. The osteolysis was filled with bone graft and a new stryker acetabular cup was implanted. A dual mobility head was used along with a new corail 12/14mhead. Doi: (b)(6) 2009; dor: (b)(6) 2022; unknown hip.
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
amy hendrickson
700 orthopaedic dr.
warsaw, IN 46581-0988
5743674841
MDR Report Key13950552
MDR Text Key288199575
Report Number1818910-2022-05792
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1218-87-352
Device Catalogue Number121887352
Device Lot Number2876576
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2009
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: 03/30/2022 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +8.5; CORAIL2 NON COL HO SIZE 11; PINNACLE 100 ACET CUP 52MM; PINNACLE MTL INS NEUT36IDX52OD
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