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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-050
Device Problem Osseointegration Problem (3003)
Patient Problems Ossification (1428); Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Inadequate Osseointegration (2646); Swelling/ Edema (4577)
Event Date 07/30/2012
Event Type  Injury  
Event Description
Mom medical records received. After review of the medical records, the patient was revised to address pseudotumor, elevated metal ions, neurolysis of sciatic nerve, complex wound of hip, heterotopic ossification and capsular redundancy. Operative note reported scars, metallosis, pseudotumor and metallic debris. There was a large amount of fluid present in the hip joint, sciatic nerve was compressed by the pseudotumor. There was also a large amount of capsular debris, pseudotumor and some heterotopic bone. Medical records indicate the cup was loosened and cystic changes were curetted from behind the cup. Doi: (b)(6) 2009; dor: (b)(6) 2012 ; right hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NamePINN SECTOR W/GRIPTION 50MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13769635
MDR Text Key287182944
Report Number1818910-2022-04679
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Followup
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Model Number1217-32-050
Device Catalogue Number121732050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2008
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: 03/15/2022 Patient Sequence Number: 1
Treatment
PINNACLE MTL INS NEUT36IDX50OD; S-ROM M HEAD 36MM +3; S-ROM*SLEEVE PRX ZTT, 14D-SM; S-ROM*STM STD 30 NK 14X8X130
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