MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP SO 9; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial hip arthroplasty, the stem subsided.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 193010 echo b-mtrc mp fp so 10 lot#: 812450, catalog#: 110017102 g7 finned 3 hole shell 50d lot#: 7107431, catalog#: 00-6250-065-30 bone screw 6.5x30 selftap lot#: j7126859, catalog#: 110024462 g7 dual mobility liner 40mm d lot#: 633890, catalog#: 650-1065 cer option type 1 tpr sleve -3 lot#: 3065028, catalog#: 110031010 vivacit-e dm bearing 28x40mm lot#: 64782770, catalog#: 650-1055 cer bioloxd option hd 28mm lot#: 3087405.Multiple reports were submitted along with this report 0001825034-2022-00058.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.One echo b-mtrc mp fp was returned and evaluated.Upon visual inspection, the device has damage in to locations on the lip of the threaded hole.There is no other visible damage to the device.The height was checked with the comparator to the print and found within the given dimensions.Complaint sample was evaluated and the reported event was not confirmed.A review of the device history records identified no deviations or anomalies during manufacturing.Upon further investigation, it was discovered that the surgeon had started utilizing a 10mm broach and then elected to implant a 9mm stem which is considered off label and would have caused the issues with the stem subsiding.The echo bi-metric microplasty hip stem surgical technique states under the stem insertion section select the echo bi-metric microplasty femoral implant that corresponds to the size of the final broach.The 9mm stem was removed and a 10mm stem was implanted with no further complications.The root cause is attributed to use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 further event information available at the time of this report.

• Brand Name: ECHO B-MTRC MP FP SO 9
• 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: 13181061
• Report Number: 0001825034-2022-00057
• Device Sequence Number: 4315025
• Product Code: JDI
• UDI-Device Identifier: 00880304697768
• UDI-Public: (01)00880304697768(17)280216(10)175900
• 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
• Device Implanted Year: 2021
• 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): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 193009
• Device Lot Number: 175900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/21/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2018
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown