MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP SO 11; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 650-0660 ¿ delta ceramic head ¿ 3030546; 110010245 ¿ g7 osseoti shell ¿ 6725596; 30103606 ¿ liner ¿ 64319477.Customer has indicated that the product will not be returned to zimmer biomet for the investigation, as the product remains implanted.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 - 03688.
Event or Problem Description
It was reported that patient presented to physician approximately 1 month post right total hip arthroplasty due to iliopsoas tendonitis and treated with injection and physical therapy.All devices remain implanted at this time.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
Upon assessment of medical records received, the surgeon states he does not think the reported complications originated from the hip implants as the patient had this before and after replacement which has been unresponsive to treatment.Therefore, this event is not reportable.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Upon assessment of medical records received, the surgeon states he does not think the reported complications originated from the hip implants as the patient had this before and after replacement which has been unresponsive to treatment.Therefore, this event is not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting mild iliopsoas tendinitis, iliopsoas injection and physical therapy prescribed.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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.

• Brand Name: ECHO B-MTRC MP FP SO 11
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10626485
• Report Number: 0001825034-2020-03689
• Device Sequence Number: 19483962
• Product Code: LPH
• UDI-Device Identifier: 00880304697782
• UDI-Public: (01)00880304697782
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K143009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 193011
• Device Lot Number: 995030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 12/01/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/23/2020; 12/23/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 71