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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  PINNACLE SECTOR II CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS, INC. 1818910  PINNACLE SECTOR II CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121722052
Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Migration (4003)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Pain (1994); Distress (2329); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)
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. Reporter is an attorney.
 
Event Description
Pinnacle litigation received. Litigation alleged pain, decreased mobility, metallic debris, loosening from acetabulum, injury, and emotional distress. Doi: (b)(6) 2010; dor: unknown; right hip.
 
Manufacturer Narrative
Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.  .
 
Manufacturer Narrative
Product complaint # (b)(4). : udi: ((b)(4).
 
Event Description
Ppf alleges metallosis and elevated metal ions but laboratory result was below normal level. Pfs also alleges limp, trouble walking, muscle spasm in thigh & hip area. After review of medical records, patient was revised to addressed mechanical complications right metal on metal tha. Revision notes indicated some scarring down to the bursa which was incised. The trunnion had no significant trunnionosis. The acetabular component remained well fixed. Added demographic data of patient, account name, surgeon, laboratory result, medical history, date of revision and product details of liner, head and cup in impacted products. Doi: (b)(6) 2010; dor: (b)(6) 2017; right hip. Cn(wipro).
 
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Brand NamePINNACLE SECTOR II CUP 52MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7832486
MDR Text Key118752767
Report Number1818910-2018-68142
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number121722052
Device Lot NumberEW6C11000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2010
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: 08/30/2018 Patient Sequence Number: 1
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