MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 10X130MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03325, 0001825034 - 2020 - 03326, 0001825034 - 2020 - 03327.
Event or Problem Description
It was reported that the surgeon reamed and broached to the appropriate size for the implant being implanted.The surgeon indicated the implants did not fit the same way the broach fit.Each of the implants included in this were immediately explanted until the desired fit of the final implant was achieved.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Cmp-0620794 this follow-up report is being submitted to relay additional information.Updated: b4, b5, g4, h2, h3, h6 complaint sample was evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Device analysis indicated that the device met specification.Device was returned and evaluated against the complaint.Visual inspection found the stem to be in good overall condition with no major damage.Scratching was observed on the neck flats and polished distal tip of the stem.Dimensional analysis was performed to identify the stem.Both the overall length and porous thickness at cross section a-a were found to be within specification for a 10mm echo stem.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 POR FMRL NC 10X130MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10443405
• Report Number: 0001825034-2020-03328
• Device Sequence Number: 14476361
• Product Code: KWA
• UDI-Device Identifier: 00887868260414
• UDI-Public: 00887868260414
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070274
• 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): 08/27/2020

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 Model Number: N/A
• Device Catalogue Number: 192010
• Device Lot Number: 540650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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