MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BI-MET CO-CR HD/NK 15X45X200; PROSTHESIS, HIP

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 - 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 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.
Additional 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 or Problem Description
It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

• Brand Name: BI-MET CO-CR HD/NK 15X45X200
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9217716
• Report Number: 0001825034-2019-04763
• Device Sequence Number: 13994876
• Product Code: JDI
• UDI-Device Identifier: 00880304222960
• UDI-Public: 00880304222960
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K992058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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 Date: 04/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 12-162490
• Device Lot Number: 307010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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 Number: 1