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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-MET CO-CR HD/NK 11X34X200; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. BI-MET CO-CR HD/NK 11X34X200; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdrs were filed for this event.Please see associated: 0001825034-2019-04760, 0001825034-2019-04761, 0001825034-2019-04762, 0001825034-2019-04778, 0001825034-2019-04770, 0001825034-2019-04776, 0001825034-2019-04763, 0001825034-2019-04764, 0001825034-2019-04773, 0001825034-2019-04771, 0001825034-2019-04766, 0001825034-2019-04767, 0001825034-2019-04772, 0001825034-2019-04768, 0001825034-2019-04774, 0001825034-2019-04775.Concomitant medical products: 11-162115 reach 15x250 lt 100% por fmrl 251140, 11-104955 mlry-hd cal w/hole 34x17x220 r 275470r, 12-162584 bi-met co-cr hd/nk 13x34x250 r 413690, 12-162485 bi-met co-cr hd/nk 13x45x200 682040, 12-162484 bi-met co-cr hd/nk 11x45x200 179580, 11-162117 reach 17x250 lt 100% por fmrl 441120, 12-162596 bi-met co-cr hd/nk 13x55x250 r 808630, 12-162485 bi-met co-cr hd/nk 13x45x200 703910, 12-162574 bi-met co-cr hd/nk 15x34x250 r 046710, 12-162588 bi-met co-cr hd/nk 11x45x250 r 821500, 12-162489 bi-met co-cr hd/nk 15x34x200 627880, 12-162490 bi-met co-cr hd/nk 15x45x200 307010, 180221 balance microp stem 17x80mm lt 193920, 12-162485 bi-met co-cr hd/nk 13x45x200 314510, 11-104973 mlry-hd cal w/hole 45x17x220 r 066930, 12-162481 bi-met co-cr hd/nk 11x34x200 009370.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during the distribution process packaging damage with sterility barrier potentially compromised was identified.No patient or surgical involvement.No further information available at this time.
 
Event Description
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
Manufacturer Narrative
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.
 
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Brand Name
BI-MET CO-CR HD/NK 11X34X200
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9217778
MDR Text Key190337021
Report Number0001825034-2019-04778
Device Sequence Number1
Product Code JDI
UDI-Device Identifier00880304222861
UDI-Public00880304222861
Combination Product (y/n)N
PMA/PMN Number
K992058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number12-162481
Device Lot Number009370
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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