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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887356
Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Patient Problems Dyspnea (1816); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Heart Failure (2206); Injury (2348); Joint Dislocation (2374); Test Result (2695); No Code Available (3191)
Event Date 08/15/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. (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
Pfs and medical records received. Pfs alleges psuedotumor, dislocation, metal wear, metallosis, pain and elevated metal ions. After review of medical records, the patient was revised due to dislocation and failed right total hip arthroplasty secondary to metal-on-metal wear debris and pseudotumor formation. Operative notes reported heterotropic ossification, a large pseudotumor and a erosive damage proximally was noted on the calcar. Medical records also indicated that patient was admitted on (b)(6) 2012 due to acute right hip pain and instability, with recurrent chest pain and congested heart failure, on (b)(6) 2011 for leg swelling, shortness of breath and infection of the right thigh and on (b)(6) 2011, patient undergone debridement to fascia of chronic wounds of the right thigh, 9 cm x 8 cm and 7 cm x 8 cm. And split-thickness skin graft to right thigh wounds, right thigh donor site. Doi: (b)(6) 2004; dor: (b)(6) 2012; right. The patient has bilateral hip implants, please see (b)(4) for the left hip.
 
Manufacturer Narrative
Udi: (b)(4). (b)(4) used to capture medical device removal and blood heavy metal increased.
 
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Brand NamePINNACLE MTL INS NEUT36IDX56OD
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
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key9396622
MDR Text Key168683052
Report Number1818910-2019-119035
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number121887356
Device Lot Number1133961
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 Received12/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2019 Patient Sequence Number: 1
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