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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 11X45X250 R; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. BI-MET CO-CR HD/NK 11X45X250 R; 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 - 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.
 
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.
 
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.
 
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Brand Name
BI-MET CO-CR HD/NK 11X45X250 R
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9217755
MDR Text Key195576146
Report Number0001825034-2019-04770
Device Sequence Number1
Product Code JDI
UDI-Device Identifier00880304223127
UDI-Public00880304223127
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 Number12-162588
Device Lot Number821500
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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