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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; PROSTHESIS, EXTREMITES
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ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; PROSTHESIS, EXTREMITES Back to Search Results
Model Number N/A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/21/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# 010000589; comp rvrs 25mm bsplt ha+adptr; lot# 296770.Item# 115313; comp rvsr shldr glnsp +3 36mm; lot# 020060.Item# 180553; comp lk scr 3.5hex 4.75x30 st; lot# 602720.Item# 180553; comp lk scr 3.5hex 4.75x30 st; lot# 042760.Item# 180554; comp lk scr 3.5hex 4.75x35 st; lot# 878350.Item# 113613; comp primary stem 13mm micro; lot# 904750.Item# 115378; comp rvs tray +10mm co 44mm; lot# 800040.Item# xl-115364; arcom xl 44-36 std +3 hmrl brg; lot# 247330.Report source - foreign: event occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02449, 0001825034-2019-04940, 0001825034-2019-04941, 0001825034-2019-04942, 0001825034-2019-04943, 0001825034-2019-04944, 0001825034-2019-04945, 0001825034-2019-04946,.
 
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately eight months post initial due to infection.A spacer mold was temporarily implanted and removed at a later date.No further information is available.
 
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Brand Name
COMP RVS CNTRL 6.5X25MM ST/RST
Common Device Name
PROSTHESIS, EXTREMITES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9311933
Report Number0001825034-2019-04938
Device Sequence Number560313
Product Code KWS
UDI-Device Identifier00880304677074
UDI-Public(01)00880304677074
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K132239
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/12/2019
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? No
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number115395
Device Lot Number522910
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/29/2019
Initial Report FDA Received Date11/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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