MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER NEUTRAL 36 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: catalog number: 51-104110, lot number:6536837, brand name: tprlc 133 t1 pps ho11x142mm.Catalog number: 010000664, lot number:6692072, brand name: g7 acetabular cup.Catalog number: 650-0660, lot number:3030942, brand name: delta ceramic fem hd.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.
Event or Problem Description
It was reported that the patient experienced increased left anterior thigh pain in moderate intensity approximately 6 months post implantation.Additional physical therapy was prescribed for six weeks.No revision procedure has been reported to date.Additional information on the reported event is unavailable.
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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a left total hip arthroplasty procedure on due to osteoarthritis.Zimmer biomet components were implanted without complications.6 months after the procedure, the patient reported increased left anterior thigh pain.1 month follow up - full weight bearing with antalgic gait, slight pain, legs equal, satisfied 3 month follow up -full weight bearing with normal gait, slight pain, legs equal, satisfied 6 month follow up - moderate pain, additional physical therapy was prescribed for 6 weeks.Reported event was confirmed by review of medical records provided.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported that the patient experienced increased left anterior thigh pain in moderate intensity approximately 6 months post implantation.Additional physical therapy was prescribed for six weeks for recurrent iliopsoas tendinitis.No revision procedure has been reported to date.Additional information on the reported event is unavailable.

• Brand Name: LINER NEUTRAL 36 MM I.D. SIZE F FOR USE WITH G7 ACETABULAR SYSTEM ONLY
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11606036
• Report Number: 0001822565-2021-00762
• Device Sequence Number: 3622521
• Product Code: JDI
• UDI-Device Identifier: 00889024518759
• UDI-Public: (01)00889024518759(17)310724(10)64449789
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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 Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 20103606
• Device Lot Number: 64449789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 07/20/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/23/2021; 08/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 67