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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 02/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: 00625006540, bone scr 6.5x40 self-tap, 61013586.00620005422, shell porous with cluster holes 54 mm o.D., 61008584.Item #: unknown, unknown stem, lot #: unknown.Item #: unknown, unknown head, lot #: unknown.Item #: unknown, unknown sleeve, lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00769, screw.0002648920 - 2019 - 00763, cup.0001822565 - 2019 - 04570, stem.0001822565 - 2019 - 04571, head.0001822565 - 2019 - 04573, sleeve.
 
Event Description
It was reported that an initial right total hip arthroplasty performed and subsequently underwent revision seven years later of the head and liner due to complications from trunnionosis.The patient underwent a second nine years post initial due to pain, wound complications, and radiolucency with apparent acetabular screw fracture on x-ray.Prior to the revision, the patient underwent a venogram with stenting of the right external iliac vein due to the loose shell occluding the vein.During the revision, the acetabular component was noted to be grossly loose and freely floating within the joint space.Additionally, three soft tissue suture abscesses were noted and excised.The head, liner, and shell were replaced and antibiotic cement beads were placed within the joint.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, d11, g4, h2, h3, h4, h6.D11: 00620005422, cup, lot no.61008584 00625006540, bone screw, lot no.61013586 00786201350, femoral stem, lot no.07886766 unknown ceramic head, lot no unknown reported event was confirmed by review of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Revision op notes identified patient revised on due to pain, swelling, and elevated chromium levels.During the revision procedure, a significant pseudotumor with surrounding tissue damage and necrosis from trunnionosis was debrided.The stem and shell remained intact, and the head and liner were replaced.Medical notes identified patient was revised due to pain, wound complications, shell loosening and radiolucency with apparent acetabular screw fracture.Lucency around acetabular component with rotation, significant lucency is seen along the acetabular screw.Fractured superior right acetabular screw.Lucency around the proximal aspect of the femoral component with bone formation and surrounding soft tissues which could be heterotopic bone formation (unconfirmed).Abnormal appearance of the right hip prosthesis suggesting loosening.Prosthesis in place that appears to be compressing the external iliac vein, massive edema of the leg.Aseptic loosening rule out possible sepsis.Ebl 850ml, prbcs infused.Severe thickened fibrous tissue noted, partial deskeletonization of the proximal femur (eto) necessary to gain access.Acetabulum too excoriated with too many cavities for good fixation of the acetabular component.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
UNKNOWN LINER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9227660
MDR Text Key164828436
Report Number0001822565-2019-04572
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/27/2019
Initial Date FDA Received10/23/2019
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received01/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10; SEE H10 NARRATIVE
Patient Outcome(s) Other;
Patient Weight78
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