MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP HO 10; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 110017105-g7 finned 4 hole shell 56f-7013000; 20104006-liner neutral 40 mm i.D.Size f for use with g7 acetabular system only-65060764; 650-1058-cer bioloxd option hd 40mm 0-3062903; 650-1065-cer option type 1 tpr sleve -3 pe 1-3048759.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.
Event or Problem Description
It was reported while canal broaching, surgeon sequentially broached from 7mm up to 10mm with zb echo micro broaches, as well as trialing.He felt the 10mm broach was the correct size, fit and fill.He asked for the 10mm echo micro implant.The 10mm implant subsided.Surgery was completed with a 11mm echo micro implant.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified there is no visible damage to the device.Additionally, dimensional analysis was performed.Analysis identified the length of the device was checked and found within conformance to the print.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information on the reported event.

• Brand Name: ECHO B-MTRC MP FP HO 10
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12915230
• Report Number: 0001825034-2021-03212
• Device Sequence Number: 17392034
• Product Code: LPH
• UDI-Device Identifier: 00880304697928
• UDI-Public: (01)00880304697928(17)310604(10)272170
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K143009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 193110
• Device Lot Number: 272170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Unknown