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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY BONE SCR 6.5X30; PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. TRILOGY BONE SCR 6.5X30; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Host-Tissue Reaction (1297); Pain (1994)
Event Date 04/01/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number:00771100900 lot number: 61356526 brand name:m / l taper stem, catalog number:00620005222 lot number:61271338 brand name: acetabular shell, catalog number:00625006530 lot number:61432050 brand name: trilogy bone screw, catalog number:00631005032 lot number:61399506 brand name: trilogy liner.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02557, 0002648920-2019-00437, 0002648920-2019-00436.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
 
Event Description
It was reported that the patient was revised due to due to pain, elevated metal ion levels, altr, loosening, and in-vivo corrosion approximately 4 years post implantation.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient underwent a revision procedure due to pain, elevated metal ions, acetabular loosening, corrosion, and altr.Upon entering the wound, fluid under pressure and benign fibrous tissue with mild perivascular lymphocytic infiltrates were observed.There was abundant amorphous eosinophilic fibrinous exudate.The acetabular component had loosened and there was corrosion at the head-neck interface.Pre-operative lab results showed that patient had elevated metal ions - cobalt : 3.7, chromium : 5.5.Post operative lab results showed that the metal ion levels had dropped; cobalt : 0.5, chromium : 0.7.The acetabular components with the bone screw, and the femoral head were removed.New zimmer biomet products were implanted.There are no other findings related to the reported event.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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
TRILOGY BONE SCR 6.5X30
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key8707333
MDR Text Key148280928
Report Number0002648920-2019-00438
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
PMA/PMN Number
K934765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/29/2019
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? Yes
Device Operator Health Professional
Device Expiration Date02/10/2020
Device Model NumberN/A
Device Catalogue Number00625006530
Device Lot Number61432050
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/24/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received10/21/2019
Supplement Dates FDA Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Required Intervention;
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