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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
Model Number 1218-87-356
Device Problem Naturally Worn (2988)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Event Date 08/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
After a review of the medical record, the patient was revised to address painful left metal-on-metal total hip arthroplasty with elevated metal ions. Patient alleges pain with range of motion and in the knee, severe sudden pain that makes difficult to walk, and elevated metal ions. Operative notes indicated that upon opening up the fascia, black stained tissue was seen translucently through thin tissue. Bulbous cystic tissue was noted when flaps were created. 7 ml of clear fluid was removed from the joint. The entire cystic structure was taken down off the bone with bleeding points were coagulated on the inside showed both whitish devitalized tissue and some mildly blackish stained gray stained tissue. The capsule appeared fibrotic. A rongeur was used to remove other small areas of metal stained tissue about the posterior tissues. Any metal stained tissue was debrided. The fibrotic anterior tissue was evaluated. It was felt that some of this represented capsular tissue. This tissue was then tensed and attempt made to remove the underlying metal stained debris about the anterior capsule. The modular head was now disimpacted from the trunnion which showed minimal metal staining. The femur was held, significant rotational pressure applied to the femur and there was no obvious motion. Dissection was performed removing any thickened fibrotic tissue anteriorly and inferiorly until full exposure was obtained around the acetabulum. What was felt to be possible osteophyte was removed anteroinferiorly as well. Significant tissue posterior to the liner was seen of yellowish nature and was obtained. The acetabulum was then cleaned and debrided of additional yellow tissue. A single screw was seen and was backed out two-thirds of the way. Significant pressure was then applied outward about the lateral border of the acetabulum and there was no obvious motion. Doi: (b)(6) 2005 - dor: (b)(6) 2019 (left hip). Please see (b)(4) for the second revision.
 
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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
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9929193
MDR Text Key189701844
Report Number1818910-2020-10253
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2009
Device Model Number1218-87-356
Device Catalogue Number121887356
Device Lot Number1829607
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 Received05/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2004
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: 04/06/2020 Patient Sequence Number: 1
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