MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 8X120MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 010000663-g7 pps ltd acet shell 52e- 6578868, 010000857-g7 neutral e1 liner 36mm e-6592218, 12-115120-cer bioloxd mod hd 36mm -3 nk-2986013.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 02027, 0001825034 - 2020 - 02028.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.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 the patient complained of severe pain with activity and was diagnosed with left hip iliopsoas/flexor tendonitis, trochanteric bursitis, and abductor tendonitis 3 months¿ post implantation.No revision has been scheduled.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.Reported event was confirmed via review of medical records by a health care professional.Review of the available records identified the following: a study patient had a left total hip arthroplasty, subsequently, she complained of severe pain with activity and was diagnosed with left hip iliopsoas/flexor tendonitis, trochanteric bursitis, and abductor tendonitis.Pt had pre-op history of trochanteric bursitis, and initial expected slower recovery time due to other comorbidities and medications r/t anxiety and insomnia, therapy may have been missed/delayed due to covid-19.Device history record (dhr) was reviewed and no discrepancies were found.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 reported event.
Additional Manufacturer Narrative
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 patient continues to experience pain, difficulty with self-care, as well as problems with ambulation at the six month and one year follow-ups.Physical therapy pre-scribed.Outcome pending.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: ECHO POR FMRL NC 8X120MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10082980
• Report Number: 0001825034-2020-02029
• Device Sequence Number: 19558329
• Product Code: KWA
• UDI-Device Identifier: 00880304463141
• UDI-Public: (01)00880304463141
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2021

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: 192008
• Device Lot Number: 083280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 08/20/2020; 02/05/2021
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 08/20/2020; 02/16/2021
• 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: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Weight: 70