MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 13X145MM; 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); Tissue Damage (2104)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: (b)(6).Concomitant medical devices: 163669 925900 32mm mod head cocr std neck; 010000666 651922 g7 pps ltd acet shell 58g; 010000851 6509364 g7 neutral e1 liner 32mm g.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device 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 - 2021 - 00375, 0001825034 - 2021 - 00376, 0001825034 - 2021 - 00377.
Event or Problem Description
It was reported that a clinical study patient underwent primary total hip arthroplasty.Subsequently, the patient experienced external rotator muscle rupture and underwent re-suture repair approximately one year post implantation.No implants were removed or exchanged, and remains implanted.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
It was reported that there was a primary left tha performed.At a follow up doctor visit, it is noted that the patient was recovering normally but when visiting with a physiotherapist, the patient more vigorously set out to practice range of motion with a pilates roller, and from this the hip became irritated with posterior pain.The patient had pain and instability noted after this event in which an mri was done, which produced results consistent with a ruptured tendon and also signified correct implant positon.The patient did not respond to conservative treatment and underwent a tendon.It was noted the fascia had been caught in the trochanter and external rotators and the patient recovered well from the procedure.The device was not removed or repositioned and remains in place.As a patient recovers from implant surgery an exercise or pt program is routinely prescribed in order for the patient to return to an optimum level of function.During the post- operative period the patient is also recovering from the trauma of surgery at varying rates.Based upon the information provided, the patient was participating in a program and while performing more vigorous activities and appears injured themselves with use of a roller.Upon review of the additional information, the device was not removed, there is no allegation to the device to this event thus ruling out the device and should be non-reportable.
Event or Problem Description
It was reported that there was a primary left tha performed.At a follow up doctor visit, it is noted that the patient was recovering normally but when visiting with a physiotherapist, the patient more vigorously set out to practice range of motion with a pilates roller, and from this the hip became irritated with posterior pain.The patient had pain and instability noted after this event in which an mri was done, which produced results consistent with a ruptured tendon and also signified correct implant positon.The patient did not respond to conservative treatment and underwent a tendon.It was noted the fascia had been caught in the trochanter and external rotators and the patient recovered well from the procedure.The device was not removed or repositioned and remains in place.As a patient recovers from implant surgery an exercise or pt program is routinely prescribed in order for the patient to return to an optimum level of function.During the post- operative period the patient is also recovering from the trauma of surgery at varying rates.Based upon the information provided, the patient was participating in a program and while performing more vigorous activities and appears injured themselves with use of a roller.Upon review of the additional information, the device was not removed, there is no allegation to the device to this event thus ruling out the device and should be non-reportable.

• Brand Name: ECHO POR FMRL LAT NC 13X145MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11290488
• Report Number: 0001825034-2021-00374
• Device Sequence Number: 4759950
• Product Code: KWA
• UDI-Device Identifier: 00887868260599
• UDI-Public: (01)00887868260599
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 192113
• Device Lot Number: 841050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/07/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 83