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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS FM HD 28X-3.512/14; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. VERSYS FM HD 28X-3.512/14; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Fragmentation (1261)
Patient Problems Fall (1848); Inflammation (1932); Pain (1994); Synovitis (2094)
Event Date 02/20/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: unknown; unknown shell, unknown; unknown; unknown liner, unknown; unknown; unknown stem, unknown.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient's right hip was revised approximately 6 years post implantation due to pain, reactive synovitis and fractured ceramic head.Approximately 3 weeks prior to revision, the patient heard a breaking sound, felt intense pain, then slipped and fell.During the revision, multiple irregular fragments of tan-yellow ceramic material grossly consistent with a femoral head component were found throughout the patient's wound.The surgeon proceeded with an extensive synovectomy to try and remove embedded shards from within soft tissues.Dense connective tissue with reactive fibroblastic and vascular proliferation, inflammation, and scratches on the proximal femoral component were noted.The shell, head and liner were revised.
 
Manufacturer Narrative
Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated: reported event was confirmed by review of xrays received and revision operative notes.Device history record (dhr) was reviewed with no deviations.The root cause of the reported event cannot be determined with the information available.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
VERSYS FM HD 28X-3.512/14
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7866543
MDR Text Key119921827
Report Number0001822565-2018-04775
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK030724
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/07/2018
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 Date08/31/2015
Device Model NumberN/A
Device Catalogue Number00-6428-028-01
Device Lot Number61601781
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/16/2018
Initial Date FDA Received09/11/2018
Supplement Dates Manufacturer Received10/24/2018
Supplement Dates FDA Received11/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age48 YR
Patient Weight88
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