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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 13X34X250 R; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. BI-MET CO-CR HD/NK 13X34X250 R; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Medical Device Problem Code Packaging Problem (3007)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional 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 - 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 or Problem 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.
 
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Brand Name
BI-MET CO-CR HD/NK 13X34X250 R
Common Device Name
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9217753
Report Number0001825034-2019-04768
Device Sequence Number2132476
Product Code JDI
UDI-Device Identifier00880304223080
UDI-Public00880304223080
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K992058
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2023
Device Model NumberN/A
Device Catalogue Number12-162584
Device Lot Number413690
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/11/2019
Initial Report FDA Received Date10/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
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