MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP SO 12; PROSTHESIS, HIP

Catalog Number	193012
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported when the implant was opened, a hair appeared to be inside the secure container.There was no patient involvement.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Product was returned and the complaint has been confirmed by visual evaluation.Evaluation of the provided picture identified that there is debris inside the sterile package that has been opened.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Review of complaint history found no additional related issues for this item and the reported item and lot combination.The likely condition of the product when it left zimmer biomet control cannot be determined., a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ECHO B-MTRC MP FP SO 12
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9349005
• Report Number: 0001825034-2019-05225
• Device Sequence Number: 19542273
• Product Code: LPH
• UDI-Device Identifier: 00880304697799
• UDI-Public: 00880304697799
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Catalogue Number: 193012
• Device Lot Number: 692420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: NI
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 91